bupropion hydrochloride (xl) (43598-656)

Drug Facts

Product Profile

Brand Name bupropion hydrochloride (xl)

Generic Name bupropion hydrochloride

Labeler dr reddys laboratories inc

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

bupropion hydrochloride 300 mg/1

Manufacturer

Dr Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-656

Product ID 43598-656_dc27d1dd-5931-08dc-e053-2995a90a21f0

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207479

Listing Expiration 2026-12-31

Marketing Start 2017-04-12

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 43598656

Hyphenated Format 43598-656

Supplemental Identifiers

RxCUI

993541 993557

UPC

0343598655307 0343598656304 0343598656908 0343598655901 0343598656052 0343598655055

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

300 mg/1

source: ndc

Packaging

500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-656-05)
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-656-30)
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-656-90)

source: ndc

Packages (3)

43598-656-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-656-05) 43598-656-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-656-30) 43598-656-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-656-90)

Ingredients (1)

bupropion hydrochloride (300 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": "dc27d1dd-5931-08dc-e053-2995a90a21f0", "openfda": {"upc": ["0343598655307", "0343598656304", "0343598656908", "0343598655901", "0343598656052", "0343598655055"], "unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["d5469d64-5e74-4b7a-b4cd-551665f6adaa"], "manufacturer_name": ["Dr Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-656-05)", "package_ndc": "43598-656-05", "marketing_start_date": "20170412"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-656-30)", "package_ndc": "43598-656-30", "marketing_start_date": "20170412"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-656-90)", "package_ndc": "43598-656-90", "marketing_start_date": "20170412"}], "brand_name": "Bupropion Hydrochloride (XL)", "product_id": "43598-656_dc27d1dd-5931-08dc-e053-2995a90a21f0", "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": "43598-656", "generic_name": "bupropion hydrochloride", "labeler_name": "Dr Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "brand_name_suffix": "(XL)", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA207479", "marketing_category": "ANDA", "marketing_start_date": "20170412", "listing_expiration_date": "20261231"}