Last Updated: September 28, 2026

Details for New Drug Application (NDA): 090693

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NDA 090693 describes BUPROPION HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anbison Lab, Annora Pharma, Aurobindo Pharma Ltd, Aurobindo Pharma Usa, Chartwell Rx, Epic Pharma Llc, Granules, Graviti Pharms, Impax Labs, Invagen Pharms, Ipca Labs Ltd, Jubilant Generics, Lupin, Macleods Pharms, Ph Health, Prinston Inc, Rising, Sandoz, Sciegen Pharms, Sinotherapeutics Inc, Sun Pharm, Torrent, Twi Pharms, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, Alembic, Apotex, Cadila Pharms Ltd, Heritage Pharma, Invatech, Micro Labs, and Senores Pharms, and is included in sixty-four NDAs. It is available from sixty-nine suppliers. Additional details are available on the BUPROPION HYDROCHLORIDE profile page.

The generic ingredient in BUPROPION HYDROCHLORIDE is bupropion hydrochloride. There is one drug master file entry for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for 090693

Tradename:	BUPROPION HYDROCHLORIDE
Applicant:	Lupin
Ingredient:	bupropion hydrochloride
Patents:	0

Pharmacology for NDA: 090693

Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Suppliers and Packaging for NDA: 090693

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090693	ANDA	Major Pharmaceuticals	0904-7469	0904-7469-04	30 BLISTER PACK in 1 CARTON (0904-7469-04) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090693	ANDA	Major Pharmaceuticals	0904-7505	0904-7505-04	30 BLISTER PACK in 1 CARTON (0904-7505-04) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	150MG
Approval Date:	Apr 6, 2017	TE:	AB3	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Apr 6, 2017	TE:	AB3	RLD:	No

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