nicotine polacrilex lozenge mint

Generic: nicotine polacrilex lozenge 4 mg

Labeler: chain drug marketing association inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine polacrilex lozenge mint
Generic Name nicotine polacrilex lozenge 4 mg
Labeler chain drug marketing association inc
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
Chain Drug Marketing Association INC

Identifiers & Regulatory

Product NDC 63868-732
Product ID 63868-732_618550c1-391c-c6a7-c2b5-19d3bfc78419
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212796
Listing Expiration 2026-12-31
Marketing Start 2021-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63868732
Hyphenated Format 63868-732

Supplemental Identifiers

RxCUI
359817 359818
UNII
6M3C89ZY6R
NUI
N0000175706 M0014836

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 polacrilex lozenge mint (source: ndc)
Generic Name nicotine polacrilex lozenge 4 mg (source: ndc)
Application Number ANDA212796 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (63868-732-24) / 24 LOZENGE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (63868-732-72) / 24 LOZENGE in 1 BOTTLE
source: ndc

Packages (2)

63868-732-24 1 BOTTLE in 1 CARTON (63868-732-24) / 24 LOZENGE in 1 BOTTLE 63868-732-72 3 BOTTLE in 1 CARTON (63868-732-72) / 24 LOZENGE in 1 BOTTLE

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Nicotine Polacrilex Lozenge Mint ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "618550c1-391c-c6a7-c2b5-19d3bfc78419", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["359817", "359818"], "spl_set_id": ["e0234492-d92d-ee93-493f-1099d4544722"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Chain Drug Marketing Association INC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (63868-732-24)  / 24 LOZENGE in 1 BOTTLE", "package_ndc": "63868-732-24", "marketing_start_date": "20210401"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (63868-732-72)  / 24 LOZENGE in 1 BOTTLE", "package_ndc": "63868-732-72", "marketing_start_date": "20210401"}], "brand_name": "Nicotine Polacrilex Lozenge Mint", "product_id": "63868-732_618550c1-391c-c6a7-c2b5-19d3bfc78419", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "63868-732", "generic_name": "Nicotine Polacrilex Lozenge 4 mg", "labeler_name": "Chain Drug Marketing Association INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine Polacrilex Lozenge Mint", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA212796", "marketing_category": "ANDA", "marketing_start_date": "20210401", "listing_expiration_date": "20261231"}