nicotine

Generic: nicotine polacrilex

Labeler: mckesson corporation dba sky packaging
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine
Generic Name nicotine polacrilex
Labeler mckesson corporation dba sky packaging
Dosage Form GUM, CHEWING
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
McKesson Corporation dba SKY Packaging

Identifiers & Regulatory

Product NDC 63739-368
Product ID 63739-368_2b217980-e6ba-4e0e-a544-6d47c246961a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079038
Marketing Start 2020-04-27
Marketing End 2026-04-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63739368
Hyphenated Format 63739-368

Supplemental Identifiers

RxCUI
311975
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 ANDA079038 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (63739-368-10) / 1 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (1)

63739-368-10 100 BLISTER PACK in 1 CARTON (63739-368-10) / 1 GUM, CHEWING in 1 BLISTER PACK

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": "2b217980-e6ba-4e0e-a544-6d47c246961a", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975"], "spl_set_id": ["0d53243f-f1a7-4a1d-a93e-c0a8f05ed8df"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["McKesson Corporation dba SKY Packaging"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (63739-368-10)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "63739-368-10", "marketing_end_date": "20260427", "marketing_start_date": "20200427"}], "brand_name": "Nicotine", "product_id": "63739-368_2b217980-e6ba-4e0e-a544-6d47c246961a", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "63739-368", "generic_name": "Nicotine Polacrilex", "labeler_name": "McKesson Corporation dba SKY Packaging", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA079038", "marketing_category": "ANDA", "marketing_end_date": "20260427", "marketing_start_date": "20200427"}