nicotine transdermal system step 1

Generic: nicotine

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

Drug Facts

Product Profile

Brand Name nicotine transdermal system step 1
Generic Name nicotine
Labeler rugby laboratories
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

nicotine 21 mg/24h

Manufacturer
Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-1108
Product ID 0536-1108_83002453-670f-7a2c-a003-0bd6ee464b24
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020076
Listing Expiration 2026-12-31
Marketing Start 2016-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05361108
Hyphenated Format 0536-1108

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 transdermal system step 1 (source: ndc)
Generic Name nicotine (source: ndc)
Application Number NDA020076 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 21 mg/24h
source: ndc
Packaging
  • 14 PATCH in 1 CARTON (0536-1108-88) / 24 h in 1 PATCH
source: ndc

Packages (1)

0536-1108-88 14 PATCH in 1 CARTON (0536-1108-88) / 24 h in 1 PATCH

Ingredients (1)

nicotine (21 mg/24h)

Linked Drug Pages (1)

Nicotine transdermal system step 3, Nicotine transdermal system step 2, Nicotine transdermal system step 1 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "83002453-670f-7a2c-a003-0bd6ee464b24", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["198029", "198030", "198031"], "spl_set_id": ["ae406389-0f83-d5c8-bd2f-56075e57453a"], "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": "14 PATCH in 1 CARTON (0536-1108-88)  / 24 h in 1 PATCH", "package_ndc": "0536-1108-88", "marketing_start_date": "20160401"}], "brand_name": "Nicotine transdermal system step 1", "product_id": "0536-1108_83002453-670f-7a2c-a003-0bd6ee464b24", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "0536-1108", "generic_name": "Nicotine", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine", "brand_name_suffix": "transdermal system step 1", "active_ingredients": [{"name": "NICOTINE", "strength": "21 mg/24h"}], "application_number": "NDA020076", "marketing_category": "NDA", "marketing_start_date": "20160401", "listing_expiration_date": "20261231"}