medline

Generic: nicotine

Labeler: medline industries, lp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name medline
Generic Name nicotine
Labeler medline industries, lp
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

nicotine 21 mg/1

Manufacturer
Medline Industries, LP

Identifiers & Regulatory

Product NDC 53329-192
Product ID 53329-192_42c99420-c566-55f4-e063-6294a90ad873
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074612
Listing Expiration 2026-12-31
Marketing Start 2022-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53329192
Hyphenated Format 53329-192

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

Resolved Composition

Strengths
  • 21 mg/1
source: ndc
Packaging
  • 14 POUCH in 1 CARTON (53329-192-89) / 1 PATCH in 1 POUCH (53329-192-09)
source: ndc

Packages (1)

53329-192-89 14 POUCH in 1 CARTON (53329-192-89) / 1 PATCH in 1 POUCH (53329-192-09)

Ingredients (1)

nicotine (21 mg/1)

Linked Drug Pages (1)

Medline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "42c99420-c566-55f4-e063-6294a90ad873", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["198029", "198030", "198031"], "spl_set_id": ["e11a4b7e-6f1f-24db-e053-2a95a90a0d09"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Medline Industries, LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 POUCH in 1 CARTON (53329-192-89)  / 1 PATCH in 1 POUCH (53329-192-09)", "package_ndc": "53329-192-89", "marketing_start_date": "20220828"}], "brand_name": "Medline", "product_id": "53329-192_42c99420-c566-55f4-e063-6294a90ad873", "dosage_form": "PATCH", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "53329-192", "generic_name": "nicotine", "labeler_name": "Medline Industries, LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Medline", "active_ingredients": [{"name": "NICOTINE", "strength": "21 mg/1"}], "application_number": "ANDA074612", "marketing_category": "ANDA", "marketing_start_date": "20220630", "listing_expiration_date": "20261231"}