nicotine polacrilex (57237-323)

Drug Facts

Product Profile

Brand Name nicotine polacrilex

Generic Name nicotine polacrilex

Labeler rising pharma holdings, inc.

Dosage Form GUM, CHEWING

Routes

ORAL

Active Ingredients

nicotine 4 mg/1

Manufacturer

Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-323

Product ID 57237-323_9230a5f3-bfa3-4a70-8e91-8df2736d9a29

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA078697

Listing Expiration 2026-12-31

Marketing Start 2023-08-10

Pharmacologic Class

Established (EPC)

cholinergic nicotinic agonist [epc]

Chemical Structure

nicotine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57237323

Hyphenated Format 57237-323

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 (source: ndc)

Generic Name nicotine polacrilex (source: ndc)

Application Number ANDA078697 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

4 mg/1

source: ndc

Packaging

100 BLISTER PACK in 1 CARTON (57237-323-01) / 1 GUM, CHEWING in 1 BLISTER PACK
110 BLISTER PACK in 1 CARTON (57237-323-11) / 1 GUM, CHEWING in 1 BLISTER PACK
50 BLISTER PACK in 1 CARTON (57237-323-50) / 1 GUM, CHEWING in 1 BLISTER PACK

source: ndc

Packages (3)

57237-323-01 100 BLISTER PACK in 1 CARTON (57237-323-01) / 1 GUM, CHEWING in 1 BLISTER PACK 57237-323-11 110 BLISTER PACK in 1 CARTON (57237-323-11) / 1 GUM, CHEWING in 1 BLISTER PACK 57237-323-50 50 BLISTER PACK in 1 CARTON (57237-323-50) / 1 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Nicotine Polacrilex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "9230a5f3-bfa3-4a70-8e91-8df2736d9a29", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975"], "spl_set_id": ["e86b9c22-7ee0-4bd0-adfd-a7b087b1dd71"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (57237-323-01)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "57237-323-01", "marketing_start_date": "20230810"}, {"sample": false, "description": "110 BLISTER PACK in 1 CARTON (57237-323-11)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "57237-323-11", "marketing_start_date": "20251208"}, {"sample": false, "description": "50 BLISTER PACK in 1 CARTON (57237-323-50)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "57237-323-50", "marketing_start_date": "20251208"}], "brand_name": "Nicotine Polacrilex", "product_id": "57237-323_9230a5f3-bfa3-4a70-8e91-8df2736d9a29", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "57237-323", "generic_name": "Nicotine Polacrilex", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine Polacrilex", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA078697", "marketing_category": "ANDA", "marketing_start_date": "20230810", "listing_expiration_date": "20261231"}