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 21 mg/24h

Manufacturer
Aveva Drug Delivery Systems Inc.

Identifiers & Regulatory

Product NDC 3215-1203
Product ID 3215-1203_3b26fb9e-e895-8cf8-e063-6294a90af3b5
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 32151203
Hyphenated Format 3215-1203

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
  • 21 mg/24h
source: ndc
Packaging
  • 7 POUCH in 1 CARTON (3215-1203-07) / 24 h in 1 POUCH
  • 14 POUCH in 1 CARTON (3215-1203-14) / 24 h in 1 POUCH
  • 28 POUCH in 1 CARTON (3215-1203-28) / 24 h in 1 POUCH
source: ndc

Packages (3)

3215-1203-07 7 POUCH in 1 CARTON (3215-1203-07) / 24 h in 1 POUCH 3215-1203-14 14 POUCH in 1 CARTON (3215-1203-14) / 24 h in 1 POUCH 3215-1203-28 28 POUCH in 1 CARTON (3215-1203-28) / 24 h in 1 POUCH

Ingredients (1)

nicotine (21 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": "3b26fb9e-e895-8cf8-e063-6294a90af3b5", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["198029", "198030", "198031"], "spl_set_id": ["7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe"], "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": "7 POUCH in 1 CARTON (3215-1203-07)  / 24 h in 1 POUCH", "package_ndc": "3215-1203-07", "marketing_start_date": "20240625"}, {"sample": false, "description": "14 POUCH in 1 CARTON (3215-1203-14)  / 24 h in 1 POUCH", "package_ndc": "3215-1203-14", "marketing_start_date": "20240625"}, {"sample": false, "description": "28 POUCH in 1 CARTON (3215-1203-28)  / 24 h in 1 POUCH", "package_ndc": "3215-1203-28", "marketing_start_date": "20240625"}], "brand_name": "Nicotine Transdermal System", "product_id": "3215-1203_3b26fb9e-e895-8cf8-e063-6294a90af3b5", "dosage_form": "PATCH", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "3215-1203", "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": "21 mg/24h"}], "application_number": "ANDA074612", "marketing_category": "ANDA", "marketing_start_date": "20240625", "listing_expiration_date": "20261231"}