NDC 46708-118

Bupropion Hydrochloride

Bupropion Hydrochloride

Bupropion Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Bupropion Hydrochloride.

• Product ID: 46708-118_ef0bb8f2-7710-4236-8b47-57b74c8bca3e
• NDC: 46708-118
• Product Type: Human Prescription Drug
• Proprietary Name: Bupropion Hydrochloride
• Generic Name: Bupropion Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-06-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203013
• Labeler Name: Alembic Pharmaceuticals Limited
• Substance Name: BUPROPION HYDROCHLORIDE
• Active Ingredient Strength: 75 mg/1
• Pharm Classes: Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 46708-118-31

100 TABLET, FILM COATED in 1 BOTTLE (46708-118-31)

• Marketing Start Date: 2018-06-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46708-118-71 [46708011871]

Bupropion Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA203013
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-06-18

NDC 46708-118-31 [46708011831]

Bupropion Hydrochloride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA203013
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-06-18

Drug Details

Active Ingredients

Ingredient	Strength
BUPROPION HYDROCHLORIDE	75 mg/1

OpenFDA Data

• SPL SET ID: ef0bb8f2-7710-4236-8b47-57b74c8bca3e
• Manufacturer:
  • Alembic Pharmaceuticals Limited
• UNII:
  • ZG7E5POY8O
• RxNorm Concept Unique ID - RxCUI:
  • 993687
  • 993691
• UPC Code:
  • 0346708118310
  • 0346708127312

Pharmacological Class

• Aminoketone [EPC]
• Dopamine Uptake Inhibitors [MoA]
• Increased Dopamine Activity [PE]
• Increased Norepinephrine Activity [PE]
• Norepinephrine Uptake Inhibitors [MoA]

NDC Crossover Matching brand name "Bupropion Hydrochloride" or generic name "Bupropion Hydrochloride"

NDC	Brand Name	Generic Name
0115-5445	Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE
0115-6811	Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE
0185-0410	Bupropion Hydrochloride	Bupropion Hydrochloride
0185-0415	Bupropion Hydrochloride	Bupropion Hydrochloride
0185-1111	Bupropion Hydrochloride	Bupropion Hydrochloride
67544-892	Bupropion Hydrochloride	Bupropion Hydrochloride
68001-199	Bupropion Hydrochloride	Bupropion Hydrochloride
68001-198	Bupropion Hydrochloride	Bupropion Hydrochloride
68001-309	Bupropion Hydrochloride	Bupropion Hydrochloride
68001-308	Bupropion Hydrochloride	Bupropion Hydrochloride
68084-252	Bupropion Hydrochloride	Bupropion Hydrochloride
0440-7200	Bupropion Hydrochloride	Bupropion Hydrochloride
68084-697	BuPROPion Hydrochloride	BuPROPion Hydrochloride
68084-708	Bupropion Hydrochloride	Bupropion Hydrochloride
68180-319	Bupropion Hydrochloride	Bupropion Hydrochloride
68180-320	Bupropion Hydrochloride	Bupropion Hydrochloride
68258-7157	Bupropion hydrochloride	Bupropion hydrochloride
68258-7001	Bupropion Hydrochloride	Bupropion Hydrochloride
68788-6800	Bupropion Hydrochloride	Bupropion Hydrochloride
68788-6994	Bupropion Hydrochloride	Bupropion Hydrochloride
68788-6808	Bupropion Hydrochloride	Bupropion Hydrochloride
68788-7121	Bupropion Hydrochloride	Bupropion Hydrochloride
68788-7319	bupropion Hydrochloride	bupropion Hydrochloride
68788-7170	Bupropion Hydrochloride	Bupropion Hydrochloride
68788-7221	Bupropion Hydrochloride	Bupropion Hydrochloride
68788-9781	Bupropion Hydrochloride	Bupropion Hydrochloride
68788-9524	Bupropion Hydrochloride	Bupropion Hydrochloride
69097-917	bupropion Hydrochloride	bupropion Hydrochloride
69097-918	bupropion Hydrochloride	bupropion Hydrochloride
69844-010	bupropion hydrochloride	bupropion hydrochloride
69844-011	bupropion hydrochloride	bupropion hydrochloride
70518-0414	Bupropion Hydrochloride	Bupropion Hydrochloride
70518-0227	Bupropion Hydrochloride	Bupropion Hydrochloride
70518-0897	Bupropion Hydrochloride	Bupropion Hydrochloride
70518-0900	Bupropion Hydrochloride	Bupropion Hydrochloride
70518-0788	Bupropion Hydrochloride	Bupropion Hydrochloride
70518-0349	Bupropion Hydrochloride	Bupropion Hydrochloride
70518-1437	Bupropion Hydrochloride	Bupropion Hydrochloride
70518-1189	Bupropion Hydrochloride	Bupropion Hydrochloride
70518-1468	Bupropion Hydrochloride	Bupropion Hydrochloride
70518-1566	Bupropion Hydrochloride	Bupropion Hydrochloride
70518-1584	Bupropion Hydrochloride	Bupropion Hydrochloride
70518-0859	Bupropion Hydrochloride	Bupropion Hydrochloride
70518-1711	Bupropion Hydrochloride	Bupropion Hydrochloride
71335-0013	Bupropion Hydrochloride	Bupropion Hydrochloride
71335-0019	Bupropion Hydrochloride	Bupropion Hydrochloride
71335-0331	Bupropion Hydrochloride	Bupropion Hydrochloride
71335-0502	Bupropion Hydrochloride	Bupropion Hydrochloride
71335-0687	Bupropion Hydrochloride	Bupropion Hydrochloride
71335-0791	bupropion Hydrochloride	bupropion Hydrochloride