topcare nicotine

Generic: nicotine polacrilex

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare nicotine
Generic Name nicotine polacrilex
Labeler topco associates llc
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 2 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-403
Product ID 76162-403_25aba504-b4ce-473d-862b-c878189a50a9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077007
Listing Expiration 2026-12-31
Marketing Start 2023-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162403
Hyphenated Format 76162-403

Supplemental Identifiers

RxCUI
359817
UPC
0012345678905
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 topcare nicotine (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA077007 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 2 CONTAINER in 1 CARTON (76162-403-27) / 40 LOZENGE in 1 CONTAINER (76162-403-58)
source: ndc

Packages (1)

76162-403-27 2 CONTAINER in 1 CARTON (76162-403-27) / 40 LOZENGE in 1 CONTAINER (76162-403-58)

Ingredients (1)

nicotine (2 mg/1)

Linked Drug Pages (1)

Topcare Nicotine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "25aba504-b4ce-473d-862b-c878189a50a9", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0012345678905"], "unii": ["6M3C89ZY6R"], "rxcui": ["359817"], "spl_set_id": ["a0ceda92-78e7-417f-adfc-a085f9b18584"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CONTAINER in 1 CARTON (76162-403-27)  / 40 LOZENGE in 1 CONTAINER (76162-403-58)", "package_ndc": "76162-403-27", "marketing_start_date": "20230630"}], "brand_name": "Topcare Nicotine", "product_id": "76162-403_25aba504-b4ce-473d-862b-c878189a50a9", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "76162-403", "generic_name": "Nicotine Polacrilex", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare Nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "2 mg/1"}], "application_number": "ANDA077007", "marketing_category": "ANDA", "marketing_start_date": "20230630", "listing_expiration_date": "20261231"}