Is Zydus Pharmaceuticals USA Inc. FDA approved?

Zydus Pharmaceuticals USA Inc. holds 1 FDA-registered establishment in India. 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 Zydus Pharmaceuticals USA Inc.'s drugs manufactured?

The FDA register lists Matoda. Registered operations: analytical testing, finished drug manufacture.

What drugs does Zydus Pharmaceuticals USA Inc. make?

626 products are listed under Zydus Pharmaceuticals USA Inc. in the openFDA NDC Directory, most often as tablet; tablet, film coated; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Zydus Pharmaceuticals USA Inc.

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

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Registered sites: 1
Active NDC listings: 626
Labeller names: 3
Live patents: 0
Countries: 1
Base: India

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Zydus Pharmaceuticals LimitedRegistrant: Zydus Pharmaceuticals USA Inc.	Sub Plot No. - 20 & 21, Pharmez - Special Economic Zone, Sarkhej Bavla Road N.H. No. 8A Village.- Matoda, Taluka. - Sanand 382213 Ahmedabad, Matoda, Gujarat 382213, India (IND)	Analytical testing, Finished drug manufacture	3022238550650173735

Catalogue

Drug listings by form and route

626

626 active NDC listings: 626 human prescription drug. By marketing category: ANDA 600, NDA 12, NDA AUTHORIZED GENERIC 12, BLA 2.

Dosage form	NDCs
tablet	182
tablet, film coated	129
capsule	58
capsule, extended release	42
tablet, extended release	40
injection, solution	35
injection	24
tablet, film coated, extended release	16
injection, powder, lyophilized, for solution	11
patch, extended release	9
patch	8
powder, for suspension	8
tablet, coated	8
capsule, delayed release	7
kit	6

Route	NDCs
oral	514
intravenous	57
subcutaneous	19
transdermal	17
intramuscular	15
rectal	6
topical	6
intravitreal	2

Labeller name on the listing	NDCs
zydus pharmaceuticals usa inc.	448
zydus pharmaceuticals (usa) inc.	173
zydus pharmaceuticals usa inc	5

Catalogue

Marketed products

626

Showing 150 of 626.

Brand	Generic name	Form / route	NDC
Albuterol	Albuterol	tablet, oral	70710-1061ANDA
Albuterol	Albuterol	tablet, oral	70710-1062ANDA
Allopurinol	Allopurinol	tablet, oral	70710-1209ANDA
Allopurinol	Allopurinol	tablet, oral	70710-1210ANDA
Allopurinol	Allopurinol	tablet, oral	70710-2009ANDA
Ambrisentan	Ambrisentan	tablet, film coated, oral	70710-1179ANDA
Ambrisentan	Ambrisentan	tablet, film coated, oral	70710-1180ANDA
Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	tablet, film coated, oral	70710-1225ANDA
Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	tablet, film coated, oral	70710-1226ANDA
Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	tablet, film coated, oral	70710-1227ANDA
Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	tablet, film coated, oral	70710-1228ANDA
Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	tablet, film coated, oral	70710-1229ANDA
Amitriptyline Hydrochloride	Amitriptyline Hydrochloride	tablet, film coated, oral	70710-1230ANDA
Amlodipine Besylate	Amlodipine Besylate	tablet, oral	68382-121ANDA
Amlodipine Besylate	Amlodipine Besylate	tablet, oral	68382-122ANDA
Amlodipine Besylate	Amlodipine Besylate	tablet, oral	68382-123ANDA
Anastrozole	Anastrozole	tablet, coated, oral	68382-209ANDA
Arsenic trioxide	Arsenic trioxide	injection, solution, intravenous	68382-997ANDA
Arsenic trioxide	Arsenic trioxide	injection, solution, intravenous	70710-1610ANDA
Arsenic trioxide	Arsenic trioxide	injection, solution, intravenous	70710-1895ANDA
Arsenic trioxide	Arsenic trioxide	injection, solution, intravenous	70710-1896ANDA
Atenolol	Atenolol	tablet, oral	68382-022ANDA
Atenolol	Atenolol	tablet, oral	68382-023ANDA
Atenolol	Atenolol	tablet, oral	68382-024ANDA
Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	tablet, oral	70710-1167ANDA
Atenolol and Chlorthalidone	Atenolol and Chlorthalidone	tablet, oral	70710-1168ANDA
Azathioprine	Azathioprine	tablet, oral	68382-003ANDA
Azathioprine	Azathioprine	tablet, oral	68382-118ANDA
Azathioprine	Azathioprine	tablet, oral	68382-119ANDA
Azathioprine	Azathioprine	tablet, oral	68382-120ANDA
Azithromycin	Azithromycin	powder, for suspension, oral	70710-1457ANDA
Azithromycin	Azithromycin	powder, for suspension, oral	70710-1458ANDA
Azithromycin	Azithromycin	powder, for suspension, oral	70710-1459ANDA
Azithromycin	Azithromycin	powder, for suspension, oral	70710-1460ANDA
BEIZRAY	docetaxel	kit	70710-2091NDA
BEIZRAY	Docetaxel	injection, solution, intravenous	70710-2092NDA
BEIZRAY	docetaxel	kit	70710-2093NDA
BEIZRAY	Docetaxel	injection, solution, intravenous	70710-2152NDA
BORTEZOMIB	BORTEZOMIB	injection, powder, lyophilized, for solution, intravenous, subcutaneous	70710-1411ANDA
Baclofen	Baclofen	tablet, oral	70710-1285ANDA
Baclofen	Baclofen	tablet, oral	70710-1286ANDA
Baclofen	Baclofen	tablet, oral	70710-1609ANDA
Baclofen	Baclofen	tablet, oral	70710-1666ANDA
Benzonatate	Benzonatate	capsule, liquid filled, oral	68382-091ANDA
Benzonatate	Benzonatate	capsule, liquid filled, oral	68382-247ANDA
Benztropine Mesylate	Benztropine Mesylate	injection, intramuscular, intravenous	68382-860ANDA
Betamethasone dipropionate	Betamethasone dipropionate	cream, topical	70710-1233ANDA
Bosentan	Bosentan	tablet, coated, oral	68382-446ANDA
Bosentan	Bosentan	tablet, coated, oral	68382-447ANDA
Bromocriptine mesylate	Bromocriptine mesylate	capsule, oral	68382-110ANDA
Buspirone hydrochloride	Buspirone hydrochloride	tablet, oral	68382-180ANDA
Buspirone hydrochloride	Buspirone hydrochloride	tablet, oral	68382-181ANDA
Buspirone hydrochloride	Buspirone hydrochloride	tablet, oral	68382-182ANDA
Buspirone hydrochloride	Buspirone hydrochloride	tablet, oral	68382-183ANDA
Buspirone hydrochloride	Buspirone hydrochloride	tablet, oral	68382-623ANDA
CALCITONIN SALMON	CALCITONIN SALMON	injection, solution, intramuscular, subcutaneous	70710-1875ANDA
CARBIDOPA	CARBIDOPA	tablet, oral	70710-1221ANDA
CHOLESTYRAMINE	CHOLESTYRAMINE	powder, for suspension, oral	68382-528ANDA
CHOLESTYRAMINE	CHOLESTYRAMINE	powder, for suspension, oral	68382-529ANDA
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	ointment, topical	70710-1401ANDA
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	tablet, oral	70710-1110ANDA
Carbidopa and Levodopa	Carbidopa and Levodopa	capsule, extended release, oral	70710-2139NDA AUTHORIZED GENERIC
Carbidopa and Levodopa	Carbidopa and Levodopa	capsule, extended release, oral	70710-2140NDA AUTHORIZED GENERIC
Carbidopa and Levodopa	Carbidopa and Levodopa	capsule, extended release, oral	70710-2141NDA AUTHORIZED GENERIC
Carbidopa and Levodopa	Carbidopa and Levodopa	capsule, extended release, oral	70710-2142NDA AUTHORIZED GENERIC
Carvedilol	Carvedilol	tablet, film coated, oral	68382-092ANDA
Carvedilol	Carvedilol	tablet, film coated, oral	68382-093ANDA
Carvedilol	Carvedilol	tablet, film coated, oral	68382-094ANDA
Carvedilol	Carvedilol	tablet, film coated, oral	68382-095ANDA
Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	injection, intramuscular	70710-1849ANDA
Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	injection, intramuscular	70710-1850ANDA
Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	tablet, film coated, oral	70710-1129ANDA
Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	tablet, film coated, oral	70710-1130ANDA
Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	tablet, film coated, oral	70710-1131ANDA
Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	tablet, film coated, oral	70710-1132ANDA
Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	tablet, film coated, oral	70710-1133ANDA
Chlorthalidone	Chlorthalidone	tablet, oral	68382-970ANDA
Chlorthalidone	Chlorthalidone	tablet, oral	68382-971ANDA
Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin Phosphate and Benzoyl Peroxide	gel, topical	70710-1445ANDA
Colchicine	Colchicine	tablet, oral	70710-1351ANDA
Colchicine	Colchicine	tablet, oral	70710-1571ANDA
Colesevelam	Colesevelam	tablet, film coated, oral	68382-619ANDA
Colestipol hydrochloride	Colestipol hydrochloride	tablet, film coated, oral	70710-1467ANDA
DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	injectable, liposomal, intravenous	70710-1530ANDA
DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	injectable, liposomal, intravenous	70710-1531ANDA
Dapagliflozin	Dapagliflozin	tablet, oral	70710-1380ANDA
Dapagliflozin	Dapagliflozin	tablet, oral	70710-1381ANDA
Deflazacort	Deflazacort	tablet, oral	70710-2051ANDA
Deflazacort	Deflazacort	tablet, oral	70710-2052ANDA
Deflazacort	Deflazacort	tablet, oral	70710-2053ANDA
Deflazacort	Deflazacort	tablet, oral	70710-2054ANDA
Deflazacort Oral Suspension	Deflazacort	suspension, oral	70710-2007ANDA
Diazepam	Diazepam	gel, rectal	70710-2078ANDA
Diazepam	Diazepam	gel, rectal	70710-2079ANDA
Diazepam	Diazepam	gel, rectal	70710-2080ANDA
Diclofenac Potassium	Diclofenac Potassium Tablets	tablet, film coated, oral	70710-1832ANDA
Diflunisal	Diflunisal	tablet, oral	68382-530ANDA
Dipyridamole	Dipyridamole	tablet, film coated, oral	68382-187ANDA
Dipyridamole	Dipyridamole	tablet, film coated, oral	68382-188ANDA
Dipyridamole	Dipyridamole	tablet, film coated, oral	68382-189ANDA
Doxazosin	Doxazosin	tablet, oral	68382-783ANDA
Doxazosin	Doxazosin	tablet, oral	68382-784ANDA
Doxazosin	Doxazosin	tablet, oral	68382-785ANDA
Doxazosin	Doxazosin	tablet, oral	68382-786ANDA
Doxycycline	Doxycycline	injection, powder, lyophilized, for solution, intravenous	68382-910ANDA
Doxycycline	Doxycycline	injection, powder, lyophilized, for solution, intravenous	68382-911ANDA
Doxycycline	Doxycycline	tablet, film coated, oral	70710-1121ANDA
Doxycycline	Doxycycline	tablet, film coated, oral	70710-1122ANDA
Doxycycline	Doxycycline	tablet, film coated, oral	70710-1123ANDA
Doxycycline	Doxycycline	tablet, film coated, oral	70710-1124ANDA
Droxidopa	Droxidopa	capsule, oral	70710-1389ANDA
Droxidopa	Droxidopa	capsule, oral	70710-1390ANDA
Droxidopa	Droxidopa	capsule, oral	70710-1391ANDA
Dutasteride and tamsulosin hydrochloride	Dutasteride and tamsulosin hydrochloride	capsule, oral	68382-640ANDA
ELTROMBOPAG	eltrombopag	tablet, oral	70710-1395ANDA
ELTROMBOPAG	eltrombopag	tablet, oral	70710-1396ANDA
ELTROMBOPAG	eltrombopag	tablet, oral	70710-1397ANDA
ELTROMBOPAG	eltrombopag	tablet, oral	70710-1398ANDA
Eletriptan hydrobromide	Eletriptan hydrobromide	tablet, film coated, oral	68382-922ANDA
Eletriptan hydrobromide	Eletriptan hydrobromide	tablet, film coated, oral	68382-923ANDA
Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	tablet, film coated, oral	70710-1364ANDA
Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	tablet, film coated, oral	70710-1365ANDA
Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	tablet, film coated, oral	70710-1366ANDA
Emtricitabine and tenofovir disoproxil fumarate	Emtricitabine and tenofovir disoproxil fumarate	tablet, film coated, oral	70710-1367ANDA
Enoxaparin Sodium	Enoxaparin Sodium	injection, solution, intravenous, subcutaneous	70710-1757ANDA
Enoxaparin Sodium	Enoxaparin Sodium	injection, solution, intravenous, subcutaneous	70710-1758ANDA
Enoxaparin Sodium	Enoxaparin Sodium	injection, solution, intravenous, subcutaneous	70710-1759ANDA
Enoxaparin Sodium	Enoxaparin Sodium	injection, solution, intravenous, subcutaneous	70710-1760ANDA
Enoxaparin Sodium	Enoxaparin Sodium	injection, solution, intravenous, subcutaneous	70710-1761ANDA
Enoxaparin Sodium	Enoxaparin Sodium	injection, solution, intravenous, subcutaneous	70710-1762ANDA
Enoxaparin Sodium	Enoxaparin Sodium	injection, solution, intravenous, subcutaneous	70710-1763ANDA
Entecavir	Entecavir	tablet, film coated, oral	68382-920ANDA
Entecavir	Entecavir	tablet, film coated, oral	68382-921ANDA
Erlotinib	Erlotinib	tablet, oral	68382-913ANDA
Erlotinib	Erlotinib	tablet, oral	68382-914ANDA
Erlotinib	Erlotinib	tablet, oral	68382-915ANDA
Erythromycin	Erythromycin	tablet, film coated, oral	70710-1047ANDA
Erythromycin	Erythromycin	tablet, film coated, oral	70710-1048ANDA
Esomeprazole Magnesium	Esomeprazole Magnesium	granule, delayed release, oral	68382-848ANDA
Esomeprazole Magnesium	Esomeprazole Magnesium	granule, delayed release, oral	68382-849ANDA
Estradiol	Estradiol	patch, extended release, transdermal	70710-1191ANDA
Estradiol	Estradiol	patch, extended release, transdermal	70710-1192ANDA
Estradiol	Estradiol	patch, extended release, transdermal	70710-1193ANDA
Estradiol	Estradiol	patch, extended release, transdermal	70710-1194ANDA
Estradiol	Estradiol	patch, extended release, transdermal	70710-1195ANDA
Etodolac	Etodolac	tablet, film coated, extended release, oral	68382-271ANDA
Etodolac	Etodolac	tablet, film coated, extended release, oral	68382-272ANDA
Etodolac	Etodolac	tablet, film coated, extended release, oral	68382-273ANDA
Exemestane	Exemestane	tablet, oral	68382-383ANDA
FAMOTIDINE	famotidine	powder, for suspension, oral	68382-444ANDA

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Enquiry

Common questions

Is Zydus Pharmaceuticals USA Inc. FDA approved?: Zydus Pharmaceuticals USA Inc. holds 1 FDA-registered establishment in India. 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 Zydus Pharmaceuticals USA Inc.'s drugs manufactured?: The FDA register lists Matoda. Registered operations: analytical testing, finished drug manufacture.
What drugs does Zydus Pharmaceuticals USA Inc. make?: 626 products are listed under Zydus Pharmaceuticals USA Inc. in the openFDA NDC Directory, most often as tablet; tablet, film coated; capsule. 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.