bupropion hydrochloride sr (43598-536)

Drug Facts

Product Profile

Brand Name bupropion hydrochloride sr

Generic Name bupropion hydrochloride

Labeler dr. reddys laboratories inc.

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

bupropion hydrochloride 100 mg/1

Manufacturer

Dr. Reddys Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-536

Product ID 43598-536_6364d3de-085f-44f8-d1e4-e6bfc5a854a7

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA205794

Listing Expiration 2026-12-31

Marketing Start 2016-08-01

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 43598536

Hyphenated Format 43598-536

Supplemental Identifiers

RxCUI

993503 993518 993536

UPC

0343598538600 0343598536606

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

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-536-01)
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-536-05)
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-536-60)

source: ndc

Packages (3)

43598-536-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-536-01) 43598-536-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-536-05) 43598-536-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-536-60)

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": "6364d3de-085f-44f8-d1e4-e6bfc5a854a7", "openfda": {"upc": ["0343598538600", "0343598536606"], "unii": ["ZG7E5POY8O"], "rxcui": ["993503", "993518", "993536"], "spl_set_id": ["6948f63b-599c-4956-a249-e9544beda9fc"], "manufacturer_name": ["Dr. Reddys Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-536-01)", "package_ndc": "43598-536-01", "marketing_start_date": "20160801"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-536-05)", "package_ndc": "43598-536-05", "marketing_start_date": "20160801"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-536-60)", "package_ndc": "43598-536-60", "marketing_start_date": "20160801"}], "brand_name": "Bupropion Hydrochloride SR", "product_id": "43598-536_6364d3de-085f-44f8-d1e4-e6bfc5a854a7", "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": "43598-536", "generic_name": "bupropion hydrochloride", "labeler_name": "Dr. Reddys Laboratories 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": "20160801", "listing_expiration_date": "20261231"}