varenicline

Generic: varenicline

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name varenicline
Generic Name varenicline
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

varenicline tartrate .5 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1613
Product ID 70710-1613_985b4791-e204-4342-9cab-052cccf4a730
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216723
Listing Expiration 2026-12-31
Marketing Start 2023-06-13

Pharmacologic Class

Classes
cholinergic agonists [moa] cholinergic receptor agonist [epc] partial cholinergic nicotinic agonist [epc] partial cholinergic nicotinic agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101613
Hyphenated Format 70710-1613

Supplemental Identifiers

RxCUI
636671 636676
UPC
0370710161361 0370710161460
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 (source: ndc)
Application Number ANDA216723 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 56 TABLET, FILM COATED in 1 BOTTLE (70710-1613-6)
source: ndc

Packages (1)

70710-1613-6 56 TABLET, FILM COATED in 1 BOTTLE (70710-1613-6)

Ingredients (1)

varenicline tartrate (.5 mg/1)

Linked Drug Pages (1)

Varenicline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "985b4791-e204-4342-9cab-052cccf4a730", "openfda": {"upc": ["0370710161361", "0370710161460"], "unii": ["82269ASB48"], "rxcui": ["636671", "636676"], "spl_set_id": ["1d4c9535-f185-4ea3-9140-60c4bb77f736"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (70710-1613-6)", "package_ndc": "70710-1613-6", "marketing_start_date": "20230613"}], "brand_name": "Varenicline", "product_id": "70710-1613_985b4791-e204-4342-9cab-052cccf4a730", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]", "Partial Cholinergic Nicotinic Agonist [EPC]", "Partial Cholinergic Nicotinic Agonists [MoA]"], "product_ndc": "70710-1613", "generic_name": "Varenicline", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varenicline", "active_ingredients": [{"name": "VARENICLINE TARTRATE", "strength": ".5 mg/1"}], "application_number": "ANDA216723", "marketing_category": "ANDA", "marketing_start_date": "20230613", "listing_expiration_date": "20261231"}