nicotine

Generic: nicotine polacrilex

Labeler: rite aid corporation
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine
Generic Name nicotine polacrilex
Labeler rite aid corporation
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
Rite Aid Corporation

Identifiers & Regulatory

Product NDC 11822-1649
Product ID 11822-1649_c458d740-6c34-4d84-b3f8-75e19ff88837
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077007
Listing Expiration 2026-12-31
Marketing Start 2024-04-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 118221649
Hyphenated Format 11822-1649

Supplemental Identifiers

RxCUI
359818
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 ANDA077007 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 2 CONTAINER in 1 CARTON (11822-1649-0) / 40 LOZENGE in 1 CONTAINER
  • 40 LOZENGE in 1 CONTAINER (11822-1649-1)
source: ndc

Packages (2)

11822-1649-0 2 CONTAINER in 1 CARTON (11822-1649-0) / 40 LOZENGE in 1 CONTAINER 11822-1649-1 40 LOZENGE in 1 CONTAINER (11822-1649-1)

Ingredients (1)

nicotine (4 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": "c458d740-6c34-4d84-b3f8-75e19ff88837", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["359818"], "spl_set_id": ["09bc9f57-fed2-42d9-b4f2-2b71b8baa0a9"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Rite Aid Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CONTAINER in 1 CARTON (11822-1649-0)  / 40 LOZENGE in 1 CONTAINER", "package_ndc": "11822-1649-0", "marketing_start_date": "20240410"}, {"sample": false, "description": "40 LOZENGE in 1 CONTAINER (11822-1649-1)", "package_ndc": "11822-1649-1", "marketing_start_date": "20240410"}], "brand_name": "Nicotine", "product_id": "11822-1649_c458d740-6c34-4d84-b3f8-75e19ff88837", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "11822-1649", "generic_name": "nicotine polacrilex", "labeler_name": "Rite Aid Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA077007", "marketing_category": "ANDA", "marketing_start_date": "20240410", "listing_expiration_date": "20261231"}