varenicline tartrate

Generic: varenicline tartrate

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline tartrate
Generic Name varenicline tartrate
Labeler micro labs limited
Dosage Form KIT
Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-475
Product ID 42571-475_426f1bdc-211b-b246-e063-6394a90a8de3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218302
Listing Expiration 2026-12-31
Marketing Start 2025-12-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571475
Hyphenated Format 42571-475

Supplemental Identifiers

RxCUI
636671 636676 749289 749788
UPC
0342571475840 0342571460884 0342571460822 0342571459826
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 tartrate (source: ndc)
Generic Name varenicline tartrate (source: ndc)
Application Number ANDA218302 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 0.5 mg
  • 1 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (42571-475-84) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

42571-475-84 1 KIT in 1 CARTON (42571-475-84) * 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 tartrate, Varenicline tartrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "426f1bdc-211b-b246-e063-6394a90a8de3", "openfda": {"upc": ["0342571475840", "0342571460884", "0342571460822", "0342571459826"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289", "749788"], "spl_set_id": ["ee603a5d-9a3c-4dbd-ba89-faf253dc8c42"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (42571-475-84)  *  11 TABLET, FILM COATED in 1 BLISTER PACK *  42 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "42571-475-84", "marketing_start_date": "20251201"}], "brand_name": "Varenicline tartrate", "product_id": "42571-475_426f1bdc-211b-b246-e063-6394a90a8de3", "dosage_form": "KIT", "product_ndc": "42571-475", "generic_name": "Varenicline tartrate", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline tartrate", "application_number": "ANDA218302", "marketing_category": "ANDA", "marketing_start_date": "20251201", "listing_expiration_date": "20261231"}