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 LOZENGE
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
Walgreens

Identifiers & Regulatory

Product NDC 0363-9580
Product ID 0363-9580_9e0dc481-384d-4c7b-a752-c0e75c3bc4f5
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209206
Marketing Start 2021-05-28
Marketing End 2027-05-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03639580
Hyphenated Format 0363-9580

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 ANDA209206 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 4 BOTTLE, PLASTIC in 1 BOX (0363-9580-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 BOX (0363-9580-24) / 24 LOZENGE in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 BOX (0363-9580-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC
  • 6 BOTTLE, PLASTIC in 1 BOX (0363-9580-44) / 24 LOZENGE in 1 BOTTLE, PLASTIC
source: ndc

Packages (4)

0363-9580-08 4 BOTTLE, PLASTIC in 1 BOX (0363-9580-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC 0363-9580-24 1 BOTTLE, PLASTIC in 1 BOX (0363-9580-24) / 24 LOZENGE in 1 BOTTLE, PLASTIC 0363-9580-27 1 BOTTLE, PLASTIC in 1 BOX (0363-9580-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC 0363-9580-44 6 BOTTLE, PLASTIC in 1 BOX (0363-9580-44) / 24 LOZENGE in 1 BOTTLE, PLASTIC

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": "9e0dc481-384d-4c7b-a752-c0e75c3bc4f5", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["359818"], "spl_set_id": ["49a8e4f0-2b4c-4928-98f8-c8f9bb17c0f4"], "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": "4 BOTTLE, PLASTIC in 1 BOX (0363-9580-08)  / 27 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "0363-9580-08", "marketing_end_date": "20270528", "marketing_start_date": "20210528"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (0363-9580-24)  / 24 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "0363-9580-24", "marketing_end_date": "20270528", "marketing_start_date": "20210528"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (0363-9580-27)  / 27 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "0363-9580-27", "marketing_end_date": "20270528", "marketing_start_date": "20210528"}, {"sample": false, "description": "6 BOTTLE, PLASTIC in 1 BOX (0363-9580-44)  / 24 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "0363-9580-44", "marketing_end_date": "20270528", "marketing_start_date": "20210528"}], "brand_name": "Nicotine", "product_id": "0363-9580_9e0dc481-384d-4c7b-a752-c0e75c3bc4f5", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "0363-9580", "generic_name": "nicotine polacrilex", "labeler_name": "Walgreens", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA209206", "marketing_category": "ANDA", "marketing_end_date": "20270528", "marketing_start_date": "20210528"}