bupropion hydrochloride sr (77771-174)

Drug Facts

Product Profile

Brand Name bupropion hydrochloride sr

Generic Name bupropion hydrochloride

Labeler radha pharmaceuticals, inc.

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

bupropion hydrochloride 100 mg/1

Manufacturer

Radha Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 77771-174

Product ID 77771-174_5a38f43e-ac1b-4cf2-b454-79d08f5dd555

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA205794

Listing Expiration 2027-12-31

Marketing Start 2021-04-15

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 77771174

Hyphenated Format 77771-174

Supplemental Identifiers

RxCUI

993503 993518 993536

UPC

0377771175054 0377771174057

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 sr (source: ndc)

Generic Name bupropion hydrochloride (source: ndc)

Application Number ANDA205794 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

100 mg/1

source: ndc

Packaging

500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-174-05)
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-174-60)

source: ndc

Packages (2)

77771-174-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-174-05) 77771-174-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-174-60)

Ingredients (1)

bupropion hydrochloride (100 mg/1)

Linked Drug Pages (1)

Bupropion Hydrochloride SR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "5a38f43e-ac1b-4cf2-b454-79d08f5dd555", "openfda": {"upc": ["0377771175054", "0377771174057"], "unii": ["ZG7E5POY8O"], "rxcui": ["993503", "993518", "993536"], "spl_set_id": ["161637d2-bc9d-4a2b-ad1f-6cc39ffd69ce"], "manufacturer_name": ["Radha Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-174-05)", "package_ndc": "77771-174-05", "marketing_start_date": "20210415"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-174-60)", "package_ndc": "77771-174-60", "marketing_start_date": "20210415"}], "brand_name": "Bupropion Hydrochloride SR", "product_id": "77771-174_5a38f43e-ac1b-4cf2-b454-79d08f5dd555", "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": "77771-174", "generic_name": "bupropion hydrochloride", "labeler_name": "Radha Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "brand_name_suffix": "SR", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA205794", "marketing_category": "ANDA", "marketing_start_date": "20210415", "listing_expiration_date": "20271231"}