nicotine

Generic: nicotine polacrilex

Labeler: rugby laboratories, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine
Generic Name nicotine polacrilex
Labeler rugby laboratories, inc.
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 2 mg/1

Manufacturer
Rugby Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0536-1337
Product ID 0536-1337_09bfc71c-cebe-4d12-8c99-d5b2017f5a79
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209206
Listing Expiration 2026-12-31
Marketing Start 2021-09-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05361337
Hyphenated Format 0536-1337

Supplemental Identifiers

RxCUI
359817
UPC
0305361337094
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
  • 2 mg/1
source: ndc
Packaging
  • 3 BOTTLE, PLASTIC in 1 BOX (0536-1337-09) / 24 LOZENGE in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 BOX (0536-1337-35) / 24 LOZENGE in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

0536-1337-09 3 BOTTLE, PLASTIC in 1 BOX (0536-1337-09) / 24 LOZENGE in 1 BOTTLE, PLASTIC 0536-1337-35 1 BOTTLE, PLASTIC in 1 BOX (0536-1337-35) / 24 LOZENGE in 1 BOTTLE, PLASTIC

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": ["ORAL"], "spl_id": "09bfc71c-cebe-4d12-8c99-d5b2017f5a79", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0305361337094"], "unii": ["6M3C89ZY6R"], "rxcui": ["359817"], "spl_set_id": ["150faf42-491f-403b-869b-48edd431d1cc"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Rugby Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE, PLASTIC in 1 BOX (0536-1337-09)  / 24 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "0536-1337-09", "marketing_start_date": "20210917"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (0536-1337-35)  / 24 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "0536-1337-35", "marketing_start_date": "20210917"}], "brand_name": "Nicotine", "product_id": "0536-1337_09bfc71c-cebe-4d12-8c99-d5b2017f5a79", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "0536-1337", "generic_name": "nicotine polacrilex", "labeler_name": "Rugby Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "2 mg/1"}], "application_number": "ANDA209206", "marketing_category": "ANDA", "marketing_start_date": "20210917", "listing_expiration_date": "20261231"}