bupropion hydrochloride

Generic: bupropion hydrochloride

Labeler: cipla usa., inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride
Generic Name bupropion hydrochloride
Labeler cipla usa., inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 300 mg/1

Manufacturer
Cipla USA., Inc.

Identifiers & Regulatory

Product NDC 69097-072
Product ID 69097-072_9c292b5a-2a09-4f01-b1fe-8652dd577542
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207479
Listing Expiration 2026-12-31
Marketing Start 2023-10-25

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 69097072
Hyphenated Format 69097-072

Supplemental Identifiers

RxCUI
993541 993557
UPC
0369097072124 0369097071127
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 ANDA207479 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69097-072-12)
source: ndc

Packages (1)

69097-072-12 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69097-072-12)

Ingredients (1)

bupropion hydrochloride (300 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": "9c292b5a-2a09-4f01-b1fe-8652dd577542", "openfda": {"upc": ["0369097072124", "0369097071127"], "unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["0abd64f7-5142-48f6-a487-3f5bdc3400de"], "manufacturer_name": ["Cipla USA., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69097-072-12)", "package_ndc": "69097-072-12", "marketing_start_date": "20231025"}], "brand_name": "Bupropion Hydrochloride", "product_id": "69097-072_9c292b5a-2a09-4f01-b1fe-8652dd577542", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Aminoketone [EPC]", "Dopamine Uptake Inhibitors [MoA]", "Increased Dopamine Activity [PE]", "Increased Norepinephrine Activity [PE]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "69097-072", "generic_name": "Bupropion hydrochloride", "labeler_name": "Cipla USA., Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA207479", "marketing_category": "ANDA", "marketing_start_date": "20231025", "listing_expiration_date": "20261231"}