Is Mission Pharmacal Company FDA approved?

Mission Pharmacal Company holds 1 FDA-registered establishment in the United States. 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 Mission Pharmacal Company's drugs manufactured?

The FDA register lists Boerne, TX. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Mission Pharmacal Company make?

27 products are listed under Mission Pharmacal Company in the openFDA NDC Directory, most often as cream; liquid; tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Mission Pharmacal Company

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

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Registered sites: 1
Active NDC listings: 27
Labeller names: 2
Live patents: 2
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Mission Pharmacal Company	38505 IH 10 West, Boerne, Texas (TX) 78006, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3000204446927726893

Catalogue

Drug listings by form and route

27 active NDC listings: 24 human prescription drug, 3 human otc drug. By marketing category: UNAPPROVED DRUG OTHER 15, NDA 8, ANDA 2, OTC MONOGRAPH DRUG 2.

Dosage form	NDCs
cream	5
liquid	3
tablet, film coated	3
emulsion	2
solution	2
tablet	2
tablet, delayed release	2
tablet, extended release	2
kit	1
lotion	1
ointment	1
shampoo	1
tablet, coated	1
tablet, sugar coated	1

Route	NDCs
topical	14
oral	12

Labeller name on the listing	NDCs
mission pharmacal company	26
mission pharmacal	1

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
11458104	THIOLA ECtiopronin	use	Nov 2038

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
AVAR	SULFACETAMIDE SODIUM, SULFUR	emulsion, topical	0178-0480UNAPPROVED DRUG OTHER
AVAR LS	SULFACETAMIDE SODIUM, SULFUR	emulsion, topical	0178-0475UNAPPROVED DRUG OTHER
Avar-e	SULFACETAMIDE SODIUM, SULFUR	cream, topical	0178-0470UNAPPROVED DRUG OTHER
Avar-e Green	SULFACETAMIDE SODIUM, SULFUR	cream, topical	0178-0460UNAPPROVED DRUG OTHER
Avar-e LS	SULFACETAMIDE SODIUM, SULFUR	cream, topical	0178-0465UNAPPROVED DRUG OTHER
CitraNatal 90 DHA	Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium	tablet, oral	0178-0821UNAPPROVED DRUG OTHER
CitraNatal Assure	ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent	kit	0178-0891UNAPPROVED DRUG OTHER
DR SMITHS DIAPER	Zinc Oxide	ointment, topical	0178-0330OTC MONOGRAPH DRUG
Ferralet 90	iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium	tablet, film coated, oral	0178-0089UNAPPROVED DRUG OTHER
Lithostat	acetohydroxamic acid	tablet, oral	0178-0500NDA
OVACE	SULFACETAMIDE SODIUM	liquid, topical	0178-0499UNAPPROVED DRUG OTHER
OVACE PLUS	SODIUM SULFACETAMIDE	liquid, topical	0178-0630UNAPPROVED DRUG OTHER
OVACE Plus	SULFACETAMIDE SODIUM	shampoo, topical	0178-0485UNAPPROVED DRUG OTHER
OVACE Plus	SULFACETAMIDE SODIUM	liquid, topical	0178-0490UNAPPROVED DRUG OTHER
Ovace Plus	SULFACETAMIDE SODIUM	lotion, topical	0178-0620UNAPPROVED DRUG OTHER
OvacePlus Plus	SULFACETAMIDE SODIUM	cream, topical	0178-0495UNAPPROVED DRUG OTHER
POTASSIUM IODIDE	POTASSIUM IODIDE	solution, oral	0178-0314ANDA
Texacort	Hydrocortisone	solution, topical	0178-0455ANDA
Theragesic	METHYL SALICYLATE	cream, topical	0178-0320OTC MONOGRAPH DRUG
Thiola	tiopronin	tablet, sugar coated, oral	0178-0900NDA
Thiola EC	tiopronin	tablet, delayed release, oral	0178-0901NDA
Thiola EC	tiopronin	tablet, delayed release, oral	0178-0902NDA
Tindamax	tinidazole	tablet, film coated, oral	0178-8250NDA
Tindamax	tinidazole	tablet, film coated, oral	0178-8500NDA
URIBEL TABS	Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate	tablet, coated, oral	0178-0745UNAPPROVED DRUG OTHER
UROCIT-K	potassium citrate	tablet, extended release, oral	0178-0610NDA
UROCIT-K	potassium citrate	tablet, extended release, oral	0178-0615NDA

Neighbours

Registered in the same town

Marp PharmaBoerne, TX

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Enquiry

Common questions

Is Mission Pharmacal Company FDA approved?: Mission Pharmacal Company holds 1 FDA-registered establishment in the United States. 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 Mission Pharmacal Company's drugs manufactured?: The FDA register lists Boerne, TX. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Mission Pharmacal Company make?: 27 products are listed under Mission Pharmacal Company in the openFDA NDC Directory, most often as cream; liquid; tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

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.