bupropion hydrochloride (xl) (77771-144)

Drug Facts

Product Profile

Brand Name bupropion hydrochloride (xl)

Generic Name bupropion hydrochloride

Labeler radha pharmaceuticals, inc.

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

bupropion hydrochloride 150 mg/1

Manufacturer

RADHA PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 77771-144

Product ID 77771-144_3bf617e4-22ef-4237-b80b-24c4c1b1bfda

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207479

Listing Expiration 2027-12-31

Marketing Start 2022-10-26

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 77771144

Hyphenated Format 77771-144

Supplemental Identifiers

RxCUI

993541 993557

UPC

0377771145903 0377771145057 0377771145309 0377771144906 0377771144302 0377771144050

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 (xl) (source: ndc)

Generic Name bupropion hydrochloride (source: ndc)

Application Number ANDA207479 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

150 mg/1

source: ndc

Packaging

500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-144-05)
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-144-30)
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-144-90)

source: ndc

Packages (3)

77771-144-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-144-05) 77771-144-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-144-30) 77771-144-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-144-90)

Ingredients (1)

bupropion hydrochloride (150 mg/1)

Linked Drug Pages (1)

Bupropion Hydrochloride (XL) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3bf617e4-22ef-4237-b80b-24c4c1b1bfda", "openfda": {"upc": ["0377771145903", "0377771145057", "0377771145309", "0377771144906", "0377771144302", "0377771144050"], "unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["16a788ff-8bd5-4f70-a3fd-a89db019e435"], "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 (77771-144-05)", "package_ndc": "77771-144-05", "marketing_start_date": "20221026"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-144-30)", "package_ndc": "77771-144-30", "marketing_start_date": "20221026"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (77771-144-90)", "package_ndc": "77771-144-90", "marketing_start_date": "20221026"}], "brand_name": "Bupropion Hydrochloride (XL)", "product_id": "77771-144_3bf617e4-22ef-4237-b80b-24c4c1b1bfda", "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": "77771-144", "generic_name": "bupropion hydrochloride", "labeler_name": "RADHA PHARMACEUTICALS, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "brand_name_suffix": "(XL)", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA207479", "marketing_category": "ANDA", "marketing_start_date": "20221026", "listing_expiration_date": "20271231"}