nicotine transdermal system

Generic: nicotine transdermal system

Labeler: aveva drug delivery systems, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine transdermal system
Generic Name nicotine transdermal system
Labeler aveva drug delivery systems, inc.
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

nicotine 14 mg/24h

Manufacturer
Aveva Drug Delivery Systems, Inc.

Identifiers & Regulatory

Product NDC 3215-0121
Product ID 3215-0121_43e1a5a7-e10f-afa8-e063-6294a90a254e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074612
Listing Expiration 2026-12-31
Marketing Start 2025-11-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 32150121
Hyphenated Format 3215-0121

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 (source: ndc)
Generic Name nicotine transdermal system (source: ndc)
Application Number ANDA074612 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 14 mg/24h
source: ndc
Packaging
  • 14 PATCH in 1 CARTON (3215-0121-14) / 1 h in 1 PATCH
source: ndc

Packages (1)

3215-0121-14 14 PATCH in 1 CARTON (3215-0121-14) / 1 h in 1 PATCH

Ingredients (1)

nicotine (14 mg/24h)

Linked Drug Pages (1)

Nicotine Transdermal System ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "43e1a5a7-e10f-afa8-e063-6294a90a254e", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["198029", "198030", "198031"], "spl_set_id": ["55442645-fa9b-4a9b-81e2-345ad062a124"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Aveva Drug Delivery Systems, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 PATCH in 1 CARTON (3215-0121-14)  / 1 h in 1 PATCH", "package_ndc": "3215-0121-14", "marketing_start_date": "20251124"}], "brand_name": "Nicotine Transdermal System", "product_id": "3215-0121_43e1a5a7-e10f-afa8-e063-6294a90a254e", "dosage_form": "PATCH", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "3215-0121", "generic_name": "Nicotine Transdermal System", "labeler_name": "Aveva Drug Delivery Systems, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine Transdermal System", "active_ingredients": [{"name": "NICOTINE", "strength": "14 mg/24h"}], "application_number": "ANDA074612", "marketing_category": "ANDA", "marketing_start_date": "20251124", "listing_expiration_date": "20261231"}