nicotine

Generic: nicotine polacrilex

Labeler: safeway
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine
Generic Name nicotine polacrilex
Labeler safeway
Dosage Form GUM, CHEWING
Routes
ORAL
Active Ingredients

nicotine 2 mg/1

Manufacturer
Safeway

Identifiers & Regulatory

Product NDC 21130-389
Product ID 21130-389_8003d699-4d8c-4c38-a7b7-3cfd1b20a536
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076775
Listing Expiration 2026-12-31
Marketing Start 2024-07-17

Pharmacologic Class

Established (EPC)
cholinergic nicotinic agonist [epc]
Chemical Structure
nicotine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21130389
Hyphenated Format 21130-389

Supplemental Identifiers

RxCUI
314119
UNII
6M3C89ZY6R
NUI
N0000175706 M0014836

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 nicotine (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA076775 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 110 BLISTER PACK in 1 CARTON (21130-389-25) / 1 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (1)

21130-389-25 110 BLISTER PACK in 1 CARTON (21130-389-25) / 1 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (2 mg/1)

Linked Drug Pages (1)

nicotine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8003d699-4d8c-4c38-a7b7-3cfd1b20a536", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["314119"], "spl_set_id": ["ed4fe766-1329-4d57-894d-3b977dd07b5c"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Safeway"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "110 BLISTER PACK in 1 CARTON (21130-389-25)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "21130-389-25", "marketing_start_date": "20240717"}], "brand_name": "nicotine", "product_id": "21130-389_8003d699-4d8c-4c38-a7b7-3cfd1b20a536", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "21130-389", "generic_name": "Nicotine Polacrilex", "labeler_name": "Safeway", "product_type": "HUMAN OTC DRUG", "brand_name_base": "nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "2 mg/1"}], "application_number": "ANDA076775", "marketing_category": "ANDA", "marketing_start_date": "20240717", "listing_expiration_date": "20261231"}