varenicline tartrate

Generic: varenicline tartrate

Labeler: dr. reddys laboratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline tartrate
Generic Name varenicline tartrate
Labeler dr. reddys laboratories inc.
Dosage Form KIT
Routes
ORAL
Manufacturer
Dr. Reddys Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-023
Product ID 43598-023_65233c50-9a25-15c3-cc2b-98713a8173b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215931
Listing Expiration 2026-12-31
Marketing Start 2024-12-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598023
Hyphenated Format 43598-023

Supplemental Identifiers

RxCUI
636671 636676 749289 749788
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 ANDA215931 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 0.5 mg
  • 1 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (43598-023-53) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

43598-023-53 1 KIT in 1 CARTON (43598-023-53) * 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 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "65233c50-9a25-15c3-cc2b-98713a8173b2", "openfda": {"unii": ["82269ASB48"], "rxcui": ["636671", "636676", "749289", "749788"], "spl_set_id": ["16ee0a83-88d7-97de-1e07-f9e6dcb5c934"], "manufacturer_name": ["Dr. Reddys Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (43598-023-53)  *  11 TABLET, FILM COATED in 1 BLISTER PACK *  42 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "43598-023-53", "marketing_start_date": "20241213"}], "brand_name": "varenicline tartrate", "product_id": "43598-023_65233c50-9a25-15c3-cc2b-98713a8173b2", "dosage_form": "KIT", "product_ndc": "43598-023", "generic_name": "varenicline tartrate", "labeler_name": "Dr. Reddys Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "varenicline tartrate", "application_number": "ANDA215931", "marketing_category": "ANDA", "marketing_start_date": "20241213", "listing_expiration_date": "20261231"}