bupropion hydrochloride sr

Generic: bupropion hydrochloride

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

bupropion hydrochloride 200 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-3542
Product ID 0591-3542_46100e89-6164-4144-8f8b-761371282a01
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079095
Listing Expiration 2027-12-31
Marketing Start 2009-07-02

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 05913542
Hyphenated Format 0591-3542

Supplemental Identifiers

RxCUI
993503 993518 993536
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 ANDA079095 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3542-60)
source: ndc

Packages (1)

0591-3542-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3542-60)

Ingredients (1)

bupropion hydrochloride (200 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": "46100e89-6164-4144-8f8b-761371282a01", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993503", "993518", "993536"], "spl_set_id": ["cec41945-8d64-4793-8784-4c2b8ec37b0f"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3542-60)", "package_ndc": "0591-3542-60", "marketing_start_date": "20090702"}], "brand_name": "Bupropion Hydrochloride SR", "product_id": "0591-3542_46100e89-6164-4144-8f8b-761371282a01", "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": "0591-3542", "generic_name": "bupropion hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "brand_name_suffix": "SR", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA079095", "marketing_category": "ANDA", "marketing_start_date": "20090702", "listing_expiration_date": "20271231"}