bupropion hydrochloride

Generic: bupropion hydrochloride

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride
Generic Name bupropion hydrochloride
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

bupropion hydrochloride 100 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-127
Product ID 46708-127_b09bdaa7-0871-4741-b5cd-dd30d683613c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203013
Listing Expiration 2026-12-31
Marketing Start 2018-06-18

Pharmacologic Class

Classes
aminoketone [epc] dopamine uptake inhibitors [moa] increased dopamine activity [pe] increased norepinephrine activity [pe] norepinephrine uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708127
Hyphenated Format 46708-127

Supplemental Identifiers

RxCUI
993687 993691
UPC
0346708127312 0346708118310
UNII
ZG7E5POY8O

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bupropion hydrochloride (source: ndc)
Generic Name bupropion hydrochloride (source: ndc)
Application Number ANDA203013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (46708-127-31)
  • 500 TABLET, FILM COATED in 1 BOTTLE (46708-127-71)
source: ndc

Packages (2)

46708-127-31 100 TABLET, FILM COATED in 1 BOTTLE (46708-127-31) 46708-127-71 500 TABLET, FILM COATED in 1 BOTTLE (46708-127-71)

Ingredients (1)

bupropion hydrochloride (100 mg/1)

Linked Drug Pages (1)

Bupropion Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b09bdaa7-0871-4741-b5cd-dd30d683613c", "openfda": {"upc": ["0346708127312", "0346708118310"], "unii": ["ZG7E5POY8O"], "rxcui": ["993687", "993691"], "spl_set_id": ["ef0bb8f2-7710-4236-8b47-57b74c8bca3e"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (46708-127-31)", "package_ndc": "46708-127-31", "marketing_start_date": "20180618"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (46708-127-71)", "package_ndc": "46708-127-71", "marketing_start_date": "20180618"}], "brand_name": "Bupropion Hydrochloride", "product_id": "46708-127_b09bdaa7-0871-4741-b5cd-dd30d683613c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aminoketone [EPC]", "Dopamine Uptake Inhibitors [MoA]", "Increased Dopamine Activity [PE]", "Increased Norepinephrine Activity [PE]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "46708-127", "generic_name": "Bupropion Hydrochloride", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA203013", "marketing_category": "ANDA", "marketing_start_date": "20180618", "listing_expiration_date": "20261231"}