nicotine

Generic: nicotine polacrilex

Labeler: walgreens
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine
Generic Name nicotine polacrilex
Labeler walgreens
Dosage Form GUM, CHEWING
Routes
BUCCAL
Active Ingredients

nicotine 2 mg/1

Manufacturer
Walgreens

Identifiers & Regulatory

Product NDC 0363-9250
Product ID 0363-9250_4c379eb0-3902-4c1a-a47e-464017fb482a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079044
Marketing Start 2021-01-29
Marketing End 2027-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03639250
Hyphenated Format 0363-9250

Supplemental Identifiers

RxCUI
314119
UPC
0311917032511
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 ANDA079044 (source: ndc)
Routes
BUCCAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0363-9250-10) / 1 GUM, CHEWING in 1 BLISTER PACK
  • 160 BLISTER PACK in 1 CARTON (0363-9250-16) / 1 GUM, CHEWING in 1 BLISTER PACK
  • 20 BLISTER PACK in 1 CARTON (0363-9250-20) / 1 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (3)

0363-9250-10 100 BLISTER PACK in 1 CARTON (0363-9250-10) / 1 GUM, CHEWING in 1 BLISTER PACK 0363-9250-16 160 BLISTER PACK in 1 CARTON (0363-9250-16) / 1 GUM, CHEWING in 1 BLISTER PACK 0363-9250-20 20 BLISTER PACK in 1 CARTON (0363-9250-20) / 1 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (2 mg/1)

Linked Drug Pages (1)

Nicotine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["BUCCAL"], "spl_id": "4c379eb0-3902-4c1a-a47e-464017fb482a", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0311917032511"], "unii": ["6M3C89ZY6R"], "rxcui": ["314119"], "spl_set_id": ["cce1153e-ad7b-4c8a-a4eb-5b08b4652688"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Walgreens"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0363-9250-10)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "0363-9250-10", "marketing_end_date": "20270501", "marketing_start_date": "20210129"}, {"sample": false, "description": "160 BLISTER PACK in 1 CARTON (0363-9250-16)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "0363-9250-16", "marketing_end_date": "20270501", "marketing_start_date": "20210129"}, {"sample": false, "description": "20 BLISTER PACK in 1 CARTON (0363-9250-20)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "0363-9250-20", "marketing_end_date": "20270501", "marketing_start_date": "20210129"}], "brand_name": "Nicotine", "product_id": "0363-9250_4c379eb0-3902-4c1a-a47e-464017fb482a", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "0363-9250", "generic_name": "Nicotine Polacrilex", "labeler_name": "Walgreens", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "2 mg/1"}], "application_number": "ANDA079044", "marketing_category": "ANDA", "marketing_end_date": "20270501", "marketing_start_date": "20210129"}