nicotine

Generic: nicotine

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

Drug Facts

Product Profile

Brand Name nicotine
Generic Name nicotine
Labeler rugby laboratories
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

nicotine 14 mg/24h

Manufacturer
Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-5895
Product ID 0536-5895_1a266044-8837-71cc-e063-6394a90afcc0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074612
Listing Expiration 2026-12-31
Marketing Start 2024-06-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05365895
Hyphenated Format 0536-5895

Supplemental Identifiers

RxCUI
198029 198030 198031
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 (source: ndc)
Application Number ANDA074612 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 14 mg/24h
source: ndc
Packaging
  • 7 POUCH in 1 CARTON (0536-5895-53) / 1 h in 1 POUCH
  • 28 POUCH in 1 CARTON (0536-5895-71) / 1 h in 1 POUCH
  • 14 POUCH in 1 CARTON (0536-5895-88) / 1 h in 1 POUCH
source: ndc

Packages (3)

0536-5895-53 7 POUCH in 1 CARTON (0536-5895-53) / 1 h in 1 POUCH 0536-5895-71 28 POUCH in 1 CARTON (0536-5895-71) / 1 h in 1 POUCH 0536-5895-88 14 POUCH in 1 CARTON (0536-5895-88) / 1 h in 1 POUCH

Ingredients (1)

nicotine (14 mg/24h)

Linked Drug Pages (1)

Nicotine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "1a266044-8837-71cc-e063-6394a90afcc0", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["198029", "198030", "198031"], "spl_set_id": ["2dd4cbda-5c46-4655-b69d-21b7d2e912cf"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Rugby Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "7 POUCH in 1 CARTON (0536-5895-53)  / 1 h in 1 POUCH", "package_ndc": "0536-5895-53", "marketing_start_date": "20240625"}, {"sample": false, "description": "28 POUCH in 1 CARTON (0536-5895-71)  / 1 h in 1 POUCH", "package_ndc": "0536-5895-71", "marketing_start_date": "20240625"}, {"sample": false, "description": "14 POUCH in 1 CARTON (0536-5895-88)  / 1 h in 1 POUCH", "package_ndc": "0536-5895-88", "marketing_start_date": "20240625"}], "brand_name": "Nicotine", "product_id": "0536-5895_1a266044-8837-71cc-e063-6394a90afcc0", "dosage_form": "PATCH", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "0536-5895", "generic_name": "Nicotine", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "14 mg/24h"}], "application_number": "ANDA074612", "marketing_category": "ANDA", "marketing_start_date": "20240625", "listing_expiration_date": "20261231"}