varenicline

Generic: varenicline tartrate

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline tartrate
Labeler endo usa, inc.
Dosage Form KIT
Manufacturer
ENDO USA, Inc.

Identifiers & Regulatory

Product NDC 49884-944
Product ID 49884-944_98f60ed1-5da2-4d86-a953-111898a5c804
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201785
Listing Expiration 2026-12-31
Marketing Start 2021-09-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49884944
Hyphenated Format 49884-944

Supplemental Identifiers

RxCUI
636671 636676 749289
UPC
0349884156763 0349884944995
UNII
82269ASB48

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 varenicline (source: ndc)
Generic Name varenicline tartrate (source: ndc)
Application Number ANDA201785 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 0.5 mg
  • 1 mg
source: label
Packaging
  • 1 KIT in 1 BOX (49884-944-99) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

49884-944-99 1 KIT in 1 BOX (49884-944-99) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Varenicline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "98f60ed1-5da2-4d86-a953-111898a5c804", "openfda": {"upc": ["0349884156763", "0349884944995"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289"], "spl_set_id": ["9e5c0ef3-3179-4d7b-bc76-901473c73ce8"], "manufacturer_name": ["ENDO USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 BOX (49884-944-99)  *  11 TABLET, FILM COATED in 1 BLISTER PACK *  42 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "49884-944-99", "marketing_start_date": "20210921"}], "brand_name": "Varenicline", "product_id": "49884-944_98f60ed1-5da2-4d86-a953-111898a5c804", "dosage_form": "KIT", "product_ndc": "49884-944", "generic_name": "varenicline tartrate", "labeler_name": "ENDO USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline", "application_number": "ANDA201785", "marketing_category": "ANDA", "marketing_start_date": "20210921", "listing_expiration_date": "20261231"}