nicotine transdermal system (68001-434)

Drug Facts

Product Profile

Brand Name nicotine transdermal system

Generic Name nicotine transdermal system

Labeler bluepoint laboratories

Dosage Form PATCH, EXTENDED RELEASE

Routes

TRANSDERMAL

Active Ingredients

nicotine 21 mg/24h

Manufacturer

BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-434

Product ID 68001-434_312dca25-59f8-dffd-e063-6394a90adc8c

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA074612

Listing Expiration 2026-12-31

Marketing Start 2024-06-27

Pharmacologic Class

Established (EPC)

cholinergic nicotinic agonist [epc]

Chemical Structure

nicotine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001434

Hyphenated Format 68001-434

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 (68001-434-88) / 1 h in 1 POUCH
14 POUCH in 1 CARTON (68001-434-90) / 1 h in 1 POUCH
28 POUCH in 1 CARTON (68001-434-91) / 1 h in 1 POUCH

source: ndc

Packages (3)

68001-434-88 7 POUCH in 1 CARTON (68001-434-88) / 1 h in 1 POUCH 68001-434-90 14 POUCH in 1 CARTON (68001-434-90) / 1 h in 1 POUCH 68001-434-91 28 POUCH in 1 CARTON (68001-434-91) / 1 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": "312dca25-59f8-dffd-e063-6394a90adc8c", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["198029", "198030", "198031"], "spl_set_id": ["a8a769ce-e41a-696f-e053-2a95a90a6b18"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "7 POUCH in 1 CARTON (68001-434-88)  / 1 h in 1 POUCH", "package_ndc": "68001-434-88", "marketing_start_date": "20240627"}, {"sample": false, "description": "14 POUCH in 1 CARTON (68001-434-90)  / 1 h in 1 POUCH", "package_ndc": "68001-434-90", "marketing_start_date": "20240627"}, {"sample": false, "description": "28 POUCH in 1 CARTON (68001-434-91)  / 1 h in 1 POUCH", "package_ndc": "68001-434-91", "marketing_start_date": "20240627"}], "brand_name": "Nicotine Transdermal System", "product_id": "68001-434_312dca25-59f8-dffd-e063-6394a90adc8c", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "68001-434", "generic_name": "Nicotine Transdermal System", "labeler_name": "BluePoint Laboratories", "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": "20240627", "listing_expiration_date": "20261231"}