nicotine mini (63548-0262)

Drug Facts

Product Profile

Brand Name nicotine mini

Generic Name nicotine polacrilex

Labeler pld acquisitions llc dba avma pharma solutions

Dosage Form LOZENGE

Routes

ORAL

Active Ingredients

nicotine 2 mg/1

Manufacturer

PLD Acquisitions LLC DBA Avma Pharma Solutions

Identifiers & Regulatory

Product NDC 63548-0262

Product ID 63548-0262_096f4324-c2f9-4fa7-9e59-59396cf31149

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA207868

Listing Expiration 2026-12-31

Marketing Start 2019-04-01

Pharmacologic Class

Established (EPC)

cholinergic nicotinic agonist [epc]

Chemical Structure

nicotine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 635480262

Hyphenated Format 63548-0262

Supplemental Identifiers

RxCUI

359817 359818

UPC

0000000000000

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 mini (source: ndc)

Generic Name nicotine polacrilex (source: ndc)

Application Number ANDA207868 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

2 mg/1

source: ndc

Packaging

4 BOTTLE, PLASTIC in 1 BOX (63548-0262-0) / 27 LOZENGE in 1 BOTTLE, PLASTIC
3 BOTTLE, PLASTIC in 1 BOX (63548-0262-1) / 27 LOZENGE in 1 BOTTLE, PLASTIC
1 BOTTLE, PLASTIC in 1 BOX (63548-0262-7) / 27 LOZENGE in 1 BOTTLE, PLASTIC

source: ndc

Packages (3)

63548-0262-0 4 BOTTLE, PLASTIC in 1 BOX (63548-0262-0) / 27 LOZENGE in 1 BOTTLE, PLASTIC 63548-0262-1 3 BOTTLE, PLASTIC in 1 BOX (63548-0262-1) / 27 LOZENGE in 1 BOTTLE, PLASTIC 63548-0262-7 1 BOTTLE, PLASTIC in 1 BOX (63548-0262-7) / 27 LOZENGE in 1 BOTTLE, PLASTIC

Ingredients (1)

nicotine (2 mg/1)

Linked Drug Pages (1)

Nicotine Mini ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "096f4324-c2f9-4fa7-9e59-59396cf31149", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0000000000000"], "unii": ["6M3C89ZY6R"], "rxcui": ["359817", "359818"], "spl_set_id": ["71db232e-b169-47d0-b269-5e14fa75f3a2"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["PLD Acquisitions LLC DBA Avma Pharma Solutions"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BOTTLE, PLASTIC in 1 BOX (63548-0262-0)  / 27 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "63548-0262-0", "marketing_start_date": "20190401"}, {"sample": false, "description": "3 BOTTLE, PLASTIC in 1 BOX (63548-0262-1)  / 27 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "63548-0262-1", "marketing_start_date": "20190401"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (63548-0262-7)  / 27 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "63548-0262-7", "marketing_start_date": "20190401"}], "brand_name": "Nicotine Mini", "product_id": "63548-0262_096f4324-c2f9-4fa7-9e59-59396cf31149", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "63548-0262", "generic_name": "nicotine polacrilex", "labeler_name": "PLD Acquisitions LLC DBA Avma Pharma Solutions", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine", "brand_name_suffix": "Mini", "active_ingredients": [{"name": "NICOTINE", "strength": "2 mg/1"}], "application_number": "ANDA207868", "marketing_category": "ANDA", "marketing_start_date": "20190401", "listing_expiration_date": "20261231"}