Is Padagis Israel Pharmaceuticals Ltd FDA approved?

Padagis Israel Pharmaceuticals Ltd holds 2 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Padagis Israel Pharmaceuticals Ltd's drugs manufactured?

At registered sites in Israel, the United States. The FDA register lists Yeruham; Minneapolis, MN. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Padagis Israel Pharmaceuticals Ltd make?

236 products are listed under Padagis Israel Pharmaceuticals Ltd in the openFDA NDC Directory, most often as cream; gel; ointment. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Are any Padagis Israel Pharmaceuticals Ltd products in shortage?

1 presentation is currently listed in the FDA drug shortage database under Padagis Israel Pharmaceuticals Ltd, covering Bacitracin Ophthalmic Ointment.

Padagis Israel Pharmaceuticals Ltd

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 2
Active NDC listings: 235
Labeller names: 3
Live patents: 1
Shortage listings: 20
Countries: 2
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture2Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Padagis Israel Pharmaceuticals Ltd	1 Burnstein Zvi, Yeruham, 8050315, Israel (ISR)	Finished drug manufacture	3001904238600093611
Padagis US LLC	3940 Quebec Ave N, Minneapolis, Minnesota (MN) 55427, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	2127022967694121

Alert

Drug shortage listings

Drug	Presentation	Status	Availability	Posted / updated
Bacitracin Ophthalmic OintmentAnti-Infective, Ophthalmology	Bacitracin, Ophthalmic Ointment, 3.5 g (NDC 0574-4022-35)	Current	Unavailable	3 Mar 20251 Jun 2026
Aspirin SuppositoryAnalgesia/Addiction, Cardiovascular	Aspirin, Suppository, 300 mg (NDC 0574-7034-12)	To Be Discontinued	-	23 Jul 202623 Jul 2026
Belladonna and Opium SuppositoryAnalgesia/Addiction	Belladonna and Opium, Suppository, 16.2 mg; 60 mg (NDC 0574-7040-12)	To Be Discontinued	-	23 Jul 202623 Jul 2026
Belladonna and Opium SuppositoryAnalgesia/Addiction	Belladonna and Opium, Suppository, 16.2 mg; 30 mg (NDC 0574-7045-12)	To Be Discontinued	-	23 Jul 202623 Jul 2026
Belladonna and Opium SuppositoryAnalgesia/Addiction	Belladonna and Opium, Suppository, 16.2 mg; 60 mg (NDC 0574-7040-04)	To Be Discontinued	-	23 Jul 202623 Jul 2026
Belladonna and Opium SuppositoryAnalgesia/Addiction	Belladonna and Opium, Suppository, 16.2 mg; 30 mg (NDC 0574-7045-04)	To Be Discontinued	-	23 Jul 202623 Jul 2026
Hydrocortisone Acetate SuppositoryAnalgesia/Addiction, Other	Hydrocortisone Acetate, Suppository, 25 mg (NDC 0574-7090-12)	To Be Discontinued	-	23 Jul 202623 Jul 2026
Hydrocortisone Acetate SuppositoryAnalgesia/Addiction, Other	Hydrocortisone Acetate, Suppository, 30 mg (NDC 0574-7093-12)	To Be Discontinued	-	23 Jul 202623 Jul 2026
Hydromorphone Hydrochloride SuppositoryAnalgesia/Addiction	Hydromorphone Hydrochloride, Suppository, 3 mg (NDC 0574-7224-06)	To Be Discontinued	-	23 Jul 202623 Jul 2026
Morphine Sulfate SuppositoryAnalgesia/Addiction	Morphine Sulfate, Suppository, 10 mg (NDC 0574-7112-12)	To Be Discontinued	-	23 Jul 202623 Jul 2026
Morphine Sulfate SuppositoryAnalgesia/Addiction	Morphine Sulfate, Suppository, 20 mg (NDC 0574-7114-12)	To Be Discontinued	-	23 Jul 202623 Jul 2026
Morphine Sulfate SuppositoryAnalgesia/Addiction	Morphine Sulfate, Suppository, 30 mg (NDC 0574-7116-12)	To Be Discontinued	-	23 Jul 202623 Jul 2026
Morphine Sulfate SuppositoryAnalgesia/Addiction	Morphine Sulfate, Suppository, 5 mg (NDC 0574-7110-12)	To Be Discontinued	-	23 Jul 202623 Jul 2026
Podophyllum Resin Topical TinctureDermatology	Podocon 25, Topical Tincture, 1 mg/4 mL (NDC 0574-0601-15)	To Be Discontinued	-	23 Jul 202623 Jul 2026
Activated Charcoal Oral SuspensionOther	Actidose, Oral Suspension, 208 mg/1 mL (NDC 0574-0520-76)	To Be Discontinued	-	15 May 202615 May 2026
Activated Charcoal Oral SuspensionOther	Actidose Aqua, Oral Suspension, 208 mg/1 mL (NDC 0574-0521-76)	To Be Discontinued	-	15 May 202615 May 2026
Activated Charcoal Oral SuspensionOther	Actidose Aqua, Oral Suspension, 208 mg/1 mL (NDC 0574-0521-25)	To Be Discontinued	-	15 May 202615 May 2026
Activated Charcoal Oral SuspensionOther	Actidose Aqua, Oral Suspension, 208 mg/1 mL (NDC 0574-0521-74)	To Be Discontinued	-	15 May 202615 May 2026
Activated Charcoal Oral SuspensionOther	Actidose, Oral Suspension, 208 mg/1 mL (NDC 0574-0520-74)	To Be Discontinued	-	15 May 202615 May 2026
Scopolamine Transdermal SystemGastroenterology, Neurology, Other	Scopolamine, Transdermal System, 1 mg (NDC 45802-580-46)	To Be Discontinued	-	3 Nov 20253 Nov 2025

Catalogue

Drug listings by form and route

235

235 active NDC listings: 189 human prescription drug, 43 human otc drug, 3 drug for further processing. By marketing category: ANDA 174, NDA AUTHORIZED GENERIC 21, OTC MONOGRAPH DRUG 17, UNAPPROVED DRUG OTHER 13, NDA 7.

Dosage form	NDCs
cream	35
gel	30
ointment	24
suppository	16
tablet, film coated	15
solution	11
spray	10
suspension	10
capsule	8
lotion	8
aerosol, foam	7
tablet	7
kit	5
lozenge	5
patch	4

Route	NDCs
topical	114
oral	65
rectal	19
nasal	9
transdermal	6
vaginal	5
ophthalmic	4
intramuscular	2
auricular (otic)	1
intravenous	1
respiratory (inhalation)	1

Labeller name on the listing	NDCs
padagis israel pharmaceuticals ltd	172
padagis us llc	59
padagis us llc	4

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
9789057	CLINDESSEclindamycin phosphate	product	Dec 2026

Catalogue

Marketed products

236

Showing 150 of 236.

Brand	Generic name	Form / route	NDC
ACTIDOSE	activated charcoal	suspension, oral	0574-0520OTC MONOGRAPH DRUG
ACTIDOSE AQUA	activated charcoal	suspension, oral	0574-0521OTC MONOGRAPH DRUG
ADAPALENE AND BENZOYL PEROXIDE	adapalene and benzoyl peroxide	gel, topical	45802-853ANDA
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride, fluticasone propionate	spray, metered, nasal	45802-066ANDA
Acyclovir	Acyclovir	cream, topical	45802-044ANDA
Adapalene	Adapalene	cream, topical	45802-453NDA AUTHORIZED GENERIC
Alogliptin	Alogliptin	tablet, film coated, oral	45802-087NDA AUTHORIZED GENERIC
Alogliptin	Alogliptin	tablet, film coated, oral	45802-103NDA AUTHORIZED GENERIC
Alogliptin	Alogliptin	tablet, film coated, oral	45802-150NDA AUTHORIZED GENERIC
Alogliptin and Pioglitazone	Alogliptin Benzoate and Pioglitazone hydrochloride	tablet, film coated, oral	45802-260NDA AUTHORIZED GENERIC
Alogliptin and Pioglitazone	Alogliptin Benzoate and Pioglitazone hydrochloride	tablet, film coated, oral	45802-351NDA AUTHORIZED GENERIC
Alogliptin and Pioglitazone	Alogliptin Benzoate and Pioglitazone hydrochloride	tablet, film coated, oral	45802-402NDA AUTHORIZED GENERIC
Alogliptin and Pioglitazone	Alogliptin Benzoate and Pioglitazone hydrochloride	tablet, film coated, oral	45802-499NDA AUTHORIZED GENERIC
Ammonium Lactate	Ammonium Lactate	lotion, topical	45802-419ANDA
Ammonium Lactate	Ammonium Lactate	cream, topical	45802-493ANDA
BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	ointment, topical	45802-505ANDA
BRIMONIDINE	brimonidine	gel, topical	45802-078ANDA
BRINZOLAMIDE	brinzolamide	suspension/ drops, ophthalmic	0574-4012ANDA
BUDESONIDE	budesonide	aerosol, foam, rectal	45802-627ANDA
Bacitracin	Bacitracin	ointment, topical	45802-060OTC MONOGRAPH DRUG
Belladonna and Opium	ATROPA BELLADONNA and OPIUM	suppository, rectal	0574-7040UNAPPROVED DRUG OTHER
Belladonna and Opium	ATROPA BELLADONNA and OPIUM	suppository, rectal	0574-7045UNAPPROVED DRUG OTHER
Betamethasone Dipropionate	Betamethasone Dipropionate	lotion, topical	45802-021ANDA
Betamethasone Dipropionate	Betamethasone Dipropionate	cream, topical	45802-376ANDA
Betamethasone Valerate	Betamethasone Valerate	aerosol, foam, topical	45802-053ANDA
Bisacodyl	bisacodyl	suppository, rectal	0574-7050OTC MONOGRAPH DRUG
Bromocriptine mesylate	Bromocriptine mesylate	tablet, oral	0574-0106ANDA
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	syrup, oral	0574-1104ANDA
CICLOPIROX	CICLOPIROX	gel, topical	0574-2061ANDA
CLINDAMYCIN AND BENZOYL PEROXIDE	clindamycin and benzoyl peroxide	kit	45802-507ANDA
CLINDAMYCIN PHOSPHATE	clindamycin phosphate	gel, topical	45802-900ANDA
Calcipotriene and Betamethasone Dipropionate	Calcipotriene, Betamethasone Dipropionate	ointment, topical	45802-816ANDA
Cetirizine Hydrochloride	Cetirizine hydrochloride	solution, oral	45802-626ANDA
Cetirizine hydrochloride and Pseudoephedrine hydrochloride	Cetirizine hydrochloride, Pseudoephedrine hydrochloride	tablet, film coated, extended release, oral	45802-147ANDA
Childrens Acetaminophen	Acetaminophen	suspension, oral	45802-201OTC MONOGRAPH DRUG
Childrens Ibuprofen	Ibuprofen	suspension, oral	45802-133ANDA
Childrens Ibuprofen	Ibuprofen	suspension, oral	45802-140ANDA
Ciclopirox	Ciclopirox	solution, topical	45802-141ANDA
Ciclopirox	Ciclopirox	shampoo, topical	45802-401ANDA
Ciclopirox Olamine	Ciclopirox Olamine	suspension, topical	45802-400ANDA
Ciclopirox olamine	Ciclopirox olamine	cream, topical	45802-138ANDA
Clindamycin Phosphate	clindamycin phosphate	lotion, topical	45802-128ANDA
Clindamycin Phosphate	Clindamycin Phosphate	solution, topical	45802-263ANDA
Clindamycin Phosphate	Clindamycin Phosphate	solution, topical	45802-562ANDA
Clindamycin Phosphate	clindamycin phosphate	aerosol, foam, topical	45802-660ANDA
Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin Phosphate and Benzoyl Peroxide	gel, topical	45802-383ANDA
Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin Phosphate, Benzoyl Peroxide	gel, topical	45802-597ANDA
Clindesse	clindamycin phosphate	cream, vaginal	45802-042NDA
Clobetasol Propionate	Clobetasol propionate	aerosol, foam, topical	45802-437ANDA
Clobetasol Propionate	Clobetasol propionate	gel, topical	45802-925ANDA
Clotrimazole	clotrimazole	lozenge, oral	0574-0107ANDA
Compro	PROCHLORPERAZINE	suppository, rectal	0574-7226ANDA
Desonide	Desonide	ointment, topical	45802-423NDA
Desoximetasone	Desoximetasone	cream, topical	45802-495ANDA
Diclofenac Sodium	diclofenac sodium	gel, topical	45802-953ANDA
Docusate Sodium	Docusate sodium	capsule, liquid filled, oral	45802-486OTC MONOGRAPH DRUG
ESTRADIOL	estradiol	gel, topical	45802-134ANDA
ESTRADIOL	estradiol	gel, topical	45802-202ANDA
ESTRADIOL	estradiol	gel, topical	45802-310ANDA
ESTRADIOL	estradiol	gel, topical	45802-452ANDA
ESTRADIOL	estradiol	gel, topical	45802-573ANDA
Econazole Nitrate	Econazole Nitrate	cream, topical	45802-466ANDA
Ery	Erythromycin	swab, topical	45802-962ANDA
Erythromycin	Erythromycin	gel, topical	45802-966ANDA
Estradiol Vaginal	Estradiol	cream, vaginal	45802-097ANDA
Evamist	Estradiol	spray, transdermal	0574-2067NDA
FLAVOXATE HYDROCHLORIDE	FLAVOXATE HYDROCHLORIDE	tablet, film coated, oral	0574-0115ANDA
FLUOCINONIDE	fluocinonide	gel, topical	45802-761ANDA
Fexofenadine Hydrochloride	fexofenadine hydrochloride	tablet, film coated, oral	45802-847ANDA
Fluocinolone Acetonide	Fluocinolone Acetonide	oil, auricular (otic)	45802-009ANDA
Fluocinolone acetonide	Fluocinolone acetonide	oil, topical	45802-485ANDA
Flurandrenolide	Flurandrenolide	lotion, topical	45802-928ANDA
Fluticasone Propionate	Fluticasone Propionate	ointment, topical	45802-221ANDA
Fluticasone Propionate	Fluticasone Propionate	cream, topical	45802-222ANDA
Gentamicin Sulfate	Gentamicin Sulfate	ointment, topical	45802-046ANDA
Gentamicin Sulfate	Gentamicin Sulfate	cream, topical	45802-056ANDA
HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	suppository, rectal	0574-7224UNAPPROVED DRUG OTHER
Halobetasol Propionate	Halobetasol Propionate	cream, topical	45802-129ANDA
Halobetasol Propionate	Halobetasol Propionate	ointment, topical	45802-131ANDA
Hemorrhoidal	mineral oil, petrolatum, phenylephrine HCl	ointment, rectal	45802-188OTC MONOGRAPH DRUG
Hydrocortisone	Hydrocortisone	cream, topical	45802-004ANDA
Hydrocortisone	Hydrocortisone	ointment, topical	45802-014ANDA
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	suppository, rectal	0574-7090UNAPPROVED DRUG OTHER
Hydrocortisone Acetate	HYDROCORTISONE ACETATE	suppository, rectal	0574-7093UNAPPROVED DRUG OTHER
Hydrocortisone Acetate Pramoxine Hcl	Hydrocortisone Acetate Pramoxine Hcl	cream, topical	45802-472UNAPPROVED DRUG OTHER
Ibuprofen	Ibuprofen	suspension, oral	45802-952ANDA
Imiquimod	Imiquimod	cream, topical	45802-368ANDA
Ivermectin	Ivermectin	cream, topical	45802-102ANDA
Ketoconazole	Ketoconazole	shampoo, suspension, topical	45802-465ANDA
LENALIDOMIDE	lenalidomide	capsule, oral	0574-1402ANDA
LENALIDOMIDE	lenalidomide	capsule, oral	0574-1405ANDA
LENALIDOMIDE	lenalidomide	capsule, oral	0574-1410ANDA
LENALIDOMIDE	lenalidomide	capsule, oral	0574-1415ANDA
LENALIDOMIDE	lenalidomide	capsule, oral	0574-1420ANDA
LENALIDOMIDE	lenalidomide	capsule, oral	0574-1425ANDA
LIDOCAINE AND PRILOCAINE	Lidocaine and Prilocaine	cream, topical	0574-2042ANDA
LOTEPREDNOL ETABONATE	loteprednol etabonate	suspension/ drops, ophthalmic	0574-4080ANDA
LOTEPREDNOL ETABONATE	loteprednol etabonate	suspension/ drops, ophthalmic	0574-4135ANDA
Loratadine antihistamine	Loratadine	tablet, oral	45802-650ANDA
Mesalamine	Mesalamine	enema, rectal	45802-098ANDA
Mesalamine	Mesalamine	kit	45802-923ANDA
Mesalamine	Mesalamine	kit	45802-929ANDA
Methylphenidate Transdermal System	methylphenidate	patch, transdermal	0574-2410NDA AUTHORIZED GENERIC
Methylphenidate Transdermal System	methylphenidate	patch, transdermal	0574-2415NDA AUTHORIZED GENERIC
Methylphenidate Transdermal System	methylphenidate	patch, transdermal	0574-2420NDA AUTHORIZED GENERIC
Methylphenidate Transdermal System	methylphenidate	patch, transdermal	0574-2430NDA AUTHORIZED GENERIC
Midazolam Hydrochloride	Midazolam Hydrochloride	syrup, oral	0574-0150ANDA
-	Minoxidil	solution	67438-020DRUG FOR FURTHER PROCESSING
Mometasone Furoate	Mometasone Furoate	solution, topical	45802-118ANDA
Mometasone Furoate	Mometasone Furoate	ointment, topical	45802-119ANDA
Mometasone Furoate	Mometasone Furoate	cream, topical	45802-257ANDA
Morphine Sulfate	MORPHINE SULFATE	suppository, rectal	0574-7110UNAPPROVED DRUG OTHER
Morphine Sulfate	MORPHINE SULFATE	suppository, rectal	0574-7112UNAPPROVED DRUG OTHER
Morphine Sulfate	MORPHINE SULFATE	suppository, rectal	0574-7114UNAPPROVED DRUG OTHER
Morphine Sulfate	MORPHINE SULFATE	suppository, rectal	0574-7116UNAPPROVED DRUG OTHER
NALOXONE HYDROCHLORIDE	naloxone hydrochloride	spray, nasal	45802-578ANDA
NICOTINE	nicotine polacrilex	gum, chewing, oral	45802-651ANDA
NITROGLYCERIN	nitroglycerin	ointment, rectal	45802-932ANDA
NYSTATIN AND TRIAMCINOLONE ACETONIDE	nystatin, triamcinolone acetonide	cream, topical	45802-880ANDA
Naproxen Sodium	Naproxen Sodium	tablet, film coated, oral	45802-490ANDA
Nicotine Polacrilex	Nicotine Polacrilex	lozenge, oral	45802-089ANDA
Nicotine Polacrilex	Nicotine Polacrilex	lozenge, oral	45802-344ANDA
Nicotine Polacrilex	Nicotine Polacrilex	lozenge, oral	45802-873ANDA
Nicotine Polacrilex	Nicotine Polacrilex	lozenge, oral	45802-957ANDA
Nystatin	Nystatin	ointment, topical	45802-048ANDA
Nystatin	Nystatin	cream, topical	45802-059ANDA
Nystop	Nystatin	powder, topical	0574-2008ANDA
PENCICLOVIR	penciclovir	cream, topical	45802-440ANDA
PODOFILOX	PODOFILOX	solution, topical	0574-0611ANDA
Paroxetine	paroxetine	capsule, oral	0574-0279NDA AUTHORIZED GENERIC
Permethrin	Permethrin	cream, topical	45802-269ANDA
Podocon 25	Podophyllum resin	tincture, topical	0574-0601UNAPPROVED DRUG OTHER
Podofilox	Podofilox	gel, topical	0574-0621ANDA
Polyethylene Glycol 3350	Polyethylene Glycol 3350	powder, for solution, oral	45802-868ANDA
Promethazine Hydrochloride	Promethazine Hydrochloride	suppository, rectal	45802-758ANDA
Promethazine Hydrochloride	Promethazine Hydrochloride	suppository, rectal	45802-759ANDA
SELENIUM SULFIDE	SELENIUM SULFIDE	lotion, topical	45802-040ANDA
SPIRONOLACTONE	spironolactone	suspension, oral	0574-1133NDA AUTHORIZED GENERIC
SUMATRIPTAN	sumatriptan	spray, nasal	45802-598ANDA
SUMATRIPTAN	sumatriptan	spray, nasal	45802-619ANDA
Scopolamine Transdermal System	scopolamine transdermal system	patch, extended release, transdermal	45802-580ANDA
Sulfacetamide Sodium	Sulfacetamide Sodium	lotion, topical	45802-896ANDA
TAZAROTENE	tazarotene	gel, topical	45802-436ANDA
TAZAROTENE	tazarotene	gel, topical	45802-442ANDA
TAZAROTENE	tazarotene	cream, topical	45802-706ANDA
TOBRAMYCIN AND DEXAMETHASONE	tobramycin and dexamethasone	suspension/ drops, ophthalmic	0574-4031ANDA
TOFACITINIB CITRATE	Tofacitinib Citrate	tablet, film coated, extended release, oral	0574-1811ANDA
TRETINOIN	tretinoin	cream, topical	0574-2201ANDA
TRETINOIN	tretinoin	cream, topical	0574-2205ANDA
TRETINOIN	tretinoin	cream, topical	0574-2225ANDA

Neighbours

Registered in the same town

PETNET Solutions, Inc.MINNEAPOLIS, MN
Isomedix Operations IncMinneapolis, MN
Central-McGowan, Inc.Minneapolis, MN

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Enquiry

Common questions

Is Padagis Israel Pharmaceuticals Ltd FDA approved?: Padagis Israel Pharmaceuticals Ltd holds 2 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Padagis Israel Pharmaceuticals Ltd's drugs manufactured?: At registered sites in Israel, the United States. The FDA register lists Yeruham; Minneapolis, MN. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Padagis Israel Pharmaceuticals Ltd make?: 236 products are listed under Padagis Israel Pharmaceuticals Ltd in the openFDA NDC Directory, most often as cream; gel; ointment. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Are any Padagis Israel Pharmaceuticals Ltd products in shortage?: 1 presentation is currently listed in the FDA drug shortage database under Padagis Israel Pharmaceuticals Ltd, covering Bacitracin Ophthalmic Ointment.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.