bupropion hydrochloride

Generic: bupropion hydrochloride

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

Drug Facts

Product Profile

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

bupropion hydrochloride 100 mg/1

Manufacturer
Cadila Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 71209-053
Product ID 71209-053_32cbb0a3-53f7-4b34-a819-97dc82678602
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208606
Listing Expiration 2026-12-31
Marketing Start 2020-01-16

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 71209053
Hyphenated Format 71209-053

Supplemental Identifiers

RxCUI
993687 993691
UPC
0371209052115 0371209053051 0371209053174 0371209052054 0371209053112
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 ANDA208606 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (71209-053-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (71209-053-11)
  • 10 BLISTER PACK in 1 CARTON (71209-053-17) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

71209-053-05 100 TABLET, FILM COATED in 1 BOTTLE (71209-053-05) 71209-053-11 1000 TABLET, FILM COATED in 1 BOTTLE (71209-053-11) 71209-053-17 10 BLISTER PACK in 1 CARTON (71209-053-17) / 10 TABLET, FILM COATED in 1 BLISTER PACK

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": "32cbb0a3-53f7-4b34-a819-97dc82678602", "openfda": {"upc": ["0371209052115", "0371209053051", "0371209053174", "0371209052054", "0371209053112"], "unii": ["ZG7E5POY8O"], "rxcui": ["993687", "993691"], "spl_set_id": ["33210109-2ddb-4b0f-a45e-988e493ca628"], "manufacturer_name": ["Cadila Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (71209-053-05)", "package_ndc": "71209-053-05", "marketing_start_date": "20230112"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (71209-053-11)", "package_ndc": "71209-053-11", "marketing_start_date": "20230112"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (71209-053-17)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "71209-053-17", "marketing_start_date": "20230112"}], "brand_name": "Bupropion Hydrochloride", "product_id": "71209-053_32cbb0a3-53f7-4b34-a819-97dc82678602", "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": "71209-053", "generic_name": "Bupropion Hydrochloride", "labeler_name": "Cadila Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA208606", "marketing_category": "ANDA", "marketing_start_date": "20200116", "listing_expiration_date": "20261231"}