Is Mylan Institutional Inc. FDA approved?

Mylan Institutional Inc. holds no registered establishment of its own; 258 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Mylan Institutional Inc. make?

258 products are listed under Mylan Institutional Inc. in the openFDA NDC Directory, most often as injection, solution; tablet; injection, powder, lyophilized, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Mylan Institutional Inc.

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

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Registered sites: 0
Active NDC listings: 253
Labeller names: 3
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

253

253 active NDC listings: 250 human prescription drug, 3 human otc drug. By marketing category: ANDA 220, NDA 25, NDA AUTHORIZED GENERIC 4, BLA 2, UNAPPROVED DRUG OTHER 2.

Dosage form	NDCs
injection, solution	82
tablet	43
injection, powder, lyophilized, for solution	31
tablet, film coated	30
injection	22
capsule	10
injection, solution, concentrate	7
injection, powder, lyophilized, for suspension	5
kit	5
capsule, extended release	4
injection, suspension	4
tablet, extended release	2
tablet, film coated, extended release	2
capsule, delayed release pellets	1
irrigant	1

Route	NDCs
intravenous	127
oral	95
intramuscular	29
subcutaneous	22
intra-articular	8
intralesional	5
soft tissue	5
epidural	3
infiltration	2
perineural	2
intravesical	1

Labeller name on the listing	NDCs
mylan institutional llc	158
mylan institutional inc.	93
mylan institutional inc	2

Catalogue

Marketed products

258

Showing 150 of 258.

Brand	Generic name	Form / route	NDC
Abacavir Sulfate	abacavir sulfate	tablet, film coated, oral	51079-204ANDA
Acetaminophen	Acetaminophen	injection, solution, intravenous	67457-940ANDA
Acetazolamide	acetazolamide sodium	injection, powder, lyophilized, for solution, intravenous	67457-853ANDA
Adenosine	adenosine	injection, solution, intravenous	67457-856ANDA
Adenosine	adenosine	injection, solution, intravenous	67457-857ANDA
Allopurinol	allopurinol	tablet, oral	51079-205ANDA
Allopurinol	allopurinol	tablet, oral	51079-206ANDA
Aloprim	Allopurinol	injection, powder, lyophilized, for solution, intravenous	67457-187NDA
Amiodarone Hydrochloride	amiodarone hydrochloride	injection, solution, intravenous	67457-153ANDA
Amiodarone Hydrochloride	amiodarone hydrochloride	injection, solution, intravenous	72078-046ANDA
Amphotericin B liposome	Amphotericin B liposome	injection, powder, lyophilized, for suspension, intravenous	67457-926ANDA
Argatroban	argatroban	injection, solution, intravenous	67457-212ANDA
Arixtra	fondaparinux sodium	injection, solution, subcutaneous	67457-592NDA
Arixtra	fondaparinux sodium	injection, solution, subcutaneous	67457-593NDA
Arixtra	fondaparinux sodium	injection, solution, subcutaneous	67457-594NDA
Arixtra	fondaparinux sodium	injection, solution, subcutaneous	67457-595NDA
Atenolol	atenolol	tablet, oral	51079-684ANDA
Atenolol	atenolol	tablet, oral	51079-685ANDA
Atenolol	atenolol	tablet, oral	51079-759ANDA
Atorvastatin Calcium	atorvastatin calcium	tablet, film coated, oral	51079-208ANDA
Atorvastatin Calcium	atorvastatin calcium	tablet, film coated, oral	51079-209ANDA
Atorvastatin Calcium	atorvastatin calcium	tablet, film coated, oral	51079-210ANDA
Atorvastatin Calcium	atorvastatin calcium	tablet, film coated, oral	51079-211ANDA
Bivalirudin	bivalirudin	injection, powder, lyophilized, for solution, intravenous	67457-256ANDA
Buspirone Hydrochloride	buspirone hydrochloride	tablet, oral	51079-960ANDA
Buspirone Hydrochloride	buspirone hydrochloride	tablet, oral	51079-985ANDA
Buspirone Hydrochloride	buspirone hydrochloride	tablet, oral	51079-986ANDA
Buspirone Hydrochloride	buspirone hydrochloride	tablet, oral	51079-994ANDA
CIDOFOVIR	Cidofovir Anhydrous	injection, solution, intravenous	67457-210ANDA
Carbidopa and Levodopa	carbidopa and levodopa	tablet, extended release, oral	51079-923ANDA
Carbidopa and Levodopa	carbidopa and levodopa	tablet, extended release, oral	51079-978ANDA
Cetirizine Hydrochloride	cetirizine hydrochloride	tablet, film coated, oral	51079-597ANDA
Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	capsule, oral	51079-141ANDA
Chlordiazepoxide Hydrochloride	Chlordiazepoxide Hydrochloride	capsule, oral	51079-375ANDA
Chlorthalidone	chlorthalidone	tablet, oral	51079-058ANDA
Clozapine	clozapine	tablet, orally disintegrating, oral	51079-288ANDA
Clozapine	clozapine	tablet, oral	51079-749ANDA
Clozapine	clozapine	tablet, oral	51079-921ANDA
Clozapine	clozapine	tablet, oral	51079-922ANDA
DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	injection, solution, intravenous	67457-924ANDA
DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	injection, solution, intravenous	67457-925ANDA
Decitabine	decitabine	injection, powder, lyophilized, for solution, intravenous	67457-316ANDA
Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	injection, solution, intra-articular, intralesional, intramuscular, intravenous, soft tissue	67457-418ANDA
Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	injection, solution, intramuscular, intravenous	67457-420ANDA
Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	injection, solution, intra-articular, intralesional, intramuscular, intravenous, soft tissue	67457-421ANDA
Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	injection, solution, intra-articular, intralesional, intramuscular, intravenous, soft tissue	67457-422ANDA
Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	injection, solution, intra-articular, intralesional, intramuscular, intravenous, soft tissue	67457-423ANDA
Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	injection, solution, intramuscular, intravenous	67457-483ANDA
Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	injection, solution, intra-articular, intralesional, intramuscular, intravenous, soft tissue	67457-484ANDA
Dexmedetomidine	dexmedetomidine	injection, solution, concentrate, intravenous	67457-251ANDA
Diazepam	diazepam	tablet, oral	51079-284ANDA
Diazepam	diazepam	tablet, oral	51079-285ANDA
Diazepam	diazepam	tablet, oral	51079-286ANDA
Diltiazem Hydrochloride	diltiazem hydrochloride	capsule, extended release, oral	51079-924ANDA
Diltiazem Hydrochloride	diltiazem hydrochloride	capsule, extended release, oral	51079-925ANDA
Diltiazem Hydrochloride	diltiazem hydrochloride	capsule, extended release, oral	51079-926ANDA
Divalproex Sodium	divalproex sodium	tablet, film coated, extended release, oral	51079-766ANDA
Divalproex Sodium	divalproex sodium	tablet, film coated, extended release, oral	51079-767ANDA
Docetaxel	DOCETAXEL ANHYDROUS	injection, solution, intravenous	67457-531ANDA
Docetaxel	DOCETAXEL ANHYDROUS	injection, solution, intravenous	67457-532ANDA
Docetaxel	DOCETAXEL ANHYDROUS	injection, solution, intravenous	67457-533ANDA
Docetaxel	Docetaxel	injection, solution, concentrate, intravenous	67457-781ANDA
Docetaxel	DOCETAXEL ANHYDROUS	injection, solution, intravenous	72078-040ANDA
Docetaxel	DOCETAXEL ANHYDROUS	injection, solution, intravenous	72078-086ANDA
Docetaxel	DOCETAXEL ANHYDROUS	injection, solution, intravenous	72078-087ANDA
Doxepin Hydrochloride	doxepin hydrochloride	capsule, oral	51079-436ANDA
Doxepin Hydrochloride	doxepin hydrochloride	capsule, oral	51079-437ANDA
Doxepin Hydrochloride	doxepin hydrochloride	capsule, oral	51079-438ANDA
Doxepin Hydrochloride	doxepin hydrochloride	capsule, oral	51079-651ANDA
Doxorubicin Hydrochloride	Doxorubicin Hydrochloride	injection, powder, lyophilized, for solution, intravenous	67457-436ANDA
Doxycycline	Doxycycline	injection, powder, lyophilized, for solution, intravenous	67457-437ANDA
Duraclon	clonidine hydrochloride	injection, solution, epidural	67457-218NDA
EPOPROSTENOL	EPOPROSTENOL	injection, powder, lyophilized, for solution, intravenous	67457-587ANDA
EPOPROSTENOL	EPOPROSTENOL	injection, powder, lyophilized, for solution, intravenous	67457-588ANDA
Eptifibatide	eptifibatide	injection, solution, intravenous	67457-629ANDA
Eptifibatide	eptifibatide	injection, solution, intravenous	67457-630ANDA
Eptifibatide	eptifibatide	injection, solution, intravenous	67457-631ANDA
Eptifibatide	eptifibatide	injection, solution, intravenous	72078-025ANDA
Eptifibatide	eptifibatide	injection, solution, intravenous	72078-026ANDA
Eptifibatide	eptifibatide	injection, solution, intravenous	72078-027ANDA
Esmolol Hydrochloride	esmolol hydrochloride	injection, solution, intravenous	67457-182ANDA
Etomidate	Etomidate	injection, solution, intravenous	67457-902ANDA
Etomidate	Etomidate	injection, solution, intravenous	67457-903ANDA
Famotidine	Famotidine	injection, intravenous	67457-433ANDA
Famotidine	Famotidine	injection, intravenous	67457-448ANDA
Famotidine	Famotidine	injection, intravenous	67457-457ANDA
Fenofibrate	fenofibrate	tablet, film coated, oral	51079-599ANDA
Fenofibrate	fenofibrate	tablet, film coated, oral	51079-608ANDA
Ferric Carboxymaltose	Ferric Carboxymaltose	injection, solution, intravenous	67457-797ANDA
Ferric Carboxymaltose	Ferric Carboxymaltose	injection, solution, intravenous	72078-048ANDA
Ferric Carboxymaltose	Ferric Carboxymaltose	injection, solution, intravenous	72078-060ANDA
Fluphenazine Decanoate	FLUPHENAZINE DECANOATE	injection, solution, intramuscular, subcutaneous	67457-359ANDA
Fomepizole	Fomepizole	injection, solution, intravenous	67457-211ANDA
Fondaparinux Sodium	fondaparinux sodium	injection, solution, subcutaneous	67457-582NDA AUTHORIZED GENERIC
Fondaparinux Sodium	fondaparinux sodium	injection, solution, subcutaneous	67457-583NDA AUTHORIZED GENERIC
Fondaparinux Sodium	fondaparinux sodium	injection, solution, subcutaneous	67457-584NDA AUTHORIZED GENERIC
Fondaparinux Sodium	fondaparinux sodium	injection, solution, subcutaneous	67457-585NDA AUTHORIZED GENERIC
Gemcitabine	GEMCITABINE HYDROCHLORIDE	injection, solution, intravenous	67457-616ANDA
Gemcitabine	GEMCITABINE HYDROCHLORIDE	injection, solution, intravenous	67457-617ANDA
Gemcitabine	GEMCITABINE HYDROCHLORIDE	injection, solution, intravenous	67457-618ANDA
Granisetron Hydrochloride	Granisetron Hydrochloride	injection, solution, intravenous	67457-861ANDA
Granisetron Hydrochloride	Granisetron Hydrochloride	injection, solution, intravenous	67457-863ANDA
Granisetron Hydrochloride	Granisetron Hydrochloride	injection, solution, intravenous	67457-864ANDA
HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	injection, solution, intramuscular	67457-426ANDA
Haloperidol	haloperidol	tablet, oral	51079-733ANDA
Haloperidol	haloperidol	tablet, oral	51079-734ANDA
Haloperidol	haloperidol	tablet, oral	51079-735ANDA
Haloperidol	haloperidol	tablet, oral	51079-736ANDA
Haloperidol Decanoate	Haloperidol Decanoate	injection, intramuscular	67457-409ANDA
Haloperidol Decanoate	Haloperidol Decanoate	injection, intramuscular	67457-410ANDA
Hydralazine Hydrochloride	Hydralazine Hydrochloride	tablet, oral	51079-074ANDA
Hydralazine Hydrochloride	Hydralazine Hydrochloride	tablet, oral	51079-075ANDA
Hydralazine Hydrochloride	Hydralazine Hydrochloride	tablet, oral	51079-076ANDA
Imatinib Mesylate	imatinib	tablet, film coated, oral	42292-043ANDA
Imatinib Mesylate	imatinib	tablet, film coated, oral	42292-044ANDA
Iron Sucrose	Iron Sucrose	injection, solution, intravenous	67457-638ANDA
Iron Sucrose	Iron Sucrose	injection, solution, intravenous	67457-639ANDA
Iron Sucrose	Iron Sucrose	injection, solution, intravenous	67457-957ANDA
Isoniazid	Isoniazid	tablet, oral	51079-083ANDA
Isosulfan Blue	Isosulfan Blue	injection, solution, subcutaneous	67457-220ANDA
Isosulfan Blue	Isosulfan Blue	injection, solution, subcutaneous	72078-069ANDA
Isosulfan Blue	Isosulfan Blue	injection, solution, subcutaneous	72078-070ANDA
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	injection, powder, lyophilized, for suspension, intramuscular, intravenous	67457-528ANDA
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	injection, powder, lyophilized, for suspension, intramuscular, intravenous	67457-529ANDA
LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	injection, powder, lyophilized, for suspension, intramuscular, intravenous	67457-530ANDA
Lansoprazole	lansoprazole	capsule, delayed release pellets, oral	51079-121ANDA
Levetiracetam	levetiracetam	tablet, film coated, oral	51079-821ANDA
Levetiracetam	Levetiracetam	injection, intravenous	67457-255NDA
Levetiracetam	Levetiracetam	injection, intravenous	67457-265NDA
Levetiracetam	Levetiracetam	injection, intravenous	67457-266NDA
Levothyroxine Sodium	levothyroxine sodium	tablet, oral	42292-038ANDA
Levothyroxine Sodium	levothyroxine sodium	tablet, oral	42292-039ANDA
Levothyroxine Sodium	levothyroxine sodium	tablet, oral	42292-040ANDA
Levothyroxine Sodium	levothyroxine sodium	tablet, oral	42292-041ANDA
Levothyroxine Sodium	levothyroxine sodium	tablet, oral	51079-440ANDA
Levothyroxine Sodium	levothyroxine sodium	tablet, oral	51079-441ANDA
Levothyroxine Sodium	levothyroxine sodium	tablet, oral	51079-442ANDA
Levothyroxine Sodium	levothyroxine sodium	tablet, oral	51079-443ANDA
Levothyroxine Sodium	levothyroxine sodium	tablet, oral	51079-444ANDA
Levothyroxine Sodium	levothyroxine sodium	tablet, oral	51079-445ANDA
Loperamide Hydrochloride	loperamide hydrochloride	capsule, oral	51079-690ANDA
Loratadine	loratadine	tablet, oral	51079-246ANDA
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	injection, solution, intravenous	67457-323ANDA
Magnesium Chloride	magnesium chloride	injection, intravenous	67457-134UNAPPROVED DRUG OTHER
Medroxyprogesterone Acetate	Medroxyprogesterone Acetate	injection, suspension, intramuscular	67457-887ANDA
Melphalan Hydrochloride	Melphalan Hydrochloride	kit	67457-195ANDA
Meropenem	Meropenem	injection, intravenous	72078-081ANDA
Methadone Hydrochloride	Methadone Hydrochloride	injection, solution, intramuscular, intravenous, subcutaneous	67457-217NDA
Methotrexate	methotrexate	tablet, oral	51079-670ANDA
Metoclopramide	Metoclopramide	tablet, oral	51079-886ANDA

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Enquiry

Common questions

Is Mylan Institutional Inc. FDA approved?: Mylan Institutional Inc. holds no registered establishment of its own; 258 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Mylan Institutional Inc. make?: 258 products are listed under Mylan Institutional Inc. in the openFDA NDC Directory, most often as injection, solution; tablet; injection, powder, lyophilized, for solution. 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.