bupropion hydrochloride sr

Generic: bupropion hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride sr
Generic Name bupropion hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 200 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-582
Product ID 71610-582_a21c94b7-5512-4999-bb4b-308c6008569c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205794
Listing Expiration 2026-12-31
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 71610582
Hyphenated Format 71610-582

Supplemental Identifiers

RxCUI
993518 993536
UNII
ZG7E5POY8O

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
  • 200 mg/1
source: ndc
Packaging
  • 3600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-582-83)
source: ndc

Packages (1)

71610-582-83 3600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-582-83)

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": "a21c94b7-5512-4999-bb4b-308c6008569c", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993518", "993536"], "spl_set_id": ["5f8b3313-0286-499f-9235-02cdc0eb063b"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "3600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-582-83)", "package_ndc": "71610-582-83", "marketing_start_date": "20210715"}], "brand_name": "Bupropion Hydrochloride SR", "product_id": "71610-582_a21c94b7-5512-4999-bb4b-308c6008569c", "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": "71610-582", "generic_name": "bupropion hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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": "ANDA205794", "marketing_category": "ANDA", "marketing_start_date": "20210415", "listing_expiration_date": "20261231"}