nicotine polacrilex gum (63443-5057)

Drug Facts

Product Profile

Brand Name nicotine polacrilex gum

Generic Name nicotine polacrilex

Labeler fertin pharma a/s

Dosage Form GUM, CHEWING

Routes

BUCCAL

Active Ingredients

nicotine 4 mg/1

Manufacturer

Fertin Pharma A/S

Identifiers & Regulatory

Product NDC 63443-5057

Product ID 63443-5057_4b1e2904-b22d-4cb9-e063-6294a90a532c

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA214354

Listing Expiration 2027-12-31

Marketing Start 2022-12-21

Pharmacologic Class

Established (EPC)

cholinergic nicotinic agonist [epc]

Chemical Structure

nicotine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 634435057

Hyphenated Format 63443-5057

Supplemental Identifiers

RxCUI

311975

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 polacrilex gum (source: ndc)

Generic Name nicotine polacrilex (source: ndc)

Application Number ANDA214354 (source: ndc)

Routes

BUCCAL

source: ndc

Resolved Composition

Strengths

4 mg/1

source: ndc

Packaging

10 BLISTER PACK in 1 CARTON (63443-5057-1) / 10 GUM, CHEWING in 1 BLISTER PACK

source: ndc

Packages (1)

63443-5057-1 10 BLISTER PACK in 1 CARTON (63443-5057-1) / 10 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Nicotine Polacrilex Gum ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["BUCCAL"], "spl_id": "4b1e2904-b22d-4cb9-e063-6294a90a532c", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975"], "spl_set_id": ["f1774540-7c2f-c60b-e053-2995a90a1ccb"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Fertin Pharma A/S"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (63443-5057-1)  / 10 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "63443-5057-1", "marketing_start_date": "20221221"}], "brand_name": "Nicotine Polacrilex Gum", "product_id": "63443-5057_4b1e2904-b22d-4cb9-e063-6294a90a532c", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "63443-5057", "generic_name": "Nicotine Polacrilex", "labeler_name": "Fertin Pharma A/S", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine Polacrilex Gum", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA214354", "marketing_category": "ANDA", "marketing_start_date": "20221221", "listing_expiration_date": "20271231"}