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 GUM, CHEWING
Routes
ORAL
Active Ingredients

nicotine 2 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-460
Product ID 36800-460_574b6739-180d-49b8-80c9-7df963c37e79
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206394
Listing Expiration 2027-12-31
Marketing Start 2023-07-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800460
Hyphenated Format 36800-460

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 topcare nicotine (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA206394 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 110 BLISTER PACK in 1 CARTON (36800-460-25) / 1 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (1)

36800-460-25 110 BLISTER PACK in 1 CARTON (36800-460-25) / 1 GUM, CHEWING in 1 BLISTER PACK

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": "574b6739-180d-49b8-80c9-7df963c37e79", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["314119"], "spl_set_id": ["cb306cdf-bab5-4b13-986b-21ade4764f00"], "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": "110 BLISTER PACK in 1 CARTON (36800-460-25)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "36800-460-25", "marketing_start_date": "20230728"}], "brand_name": "Topcare Nicotine", "product_id": "36800-460_574b6739-180d-49b8-80c9-7df963c37e79", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "36800-460", "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": "ANDA206394", "marketing_category": "ANDA", "marketing_start_date": "20230728", "listing_expiration_date": "20271231"}