quitine nicotine

Generic: nicotine polacrilex

Labeler: quitine llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quitine nicotine
Generic Name nicotine polacrilex
Labeler quitine llc
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 2 mg/1

Manufacturer
QUITINE LLC

Identifiers & Regulatory

Product NDC 84720-000
Product ID 84720-000_a7e8138b-8884-4cc9-9827-2ecd07f11ffd
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077007
Listing Expiration 2026-12-31
Marketing Start 2024-12-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84720000
Hyphenated Format 84720-000

Supplemental Identifiers

RxCUI
359817
UPC
0012345678905
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 quitine nicotine (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA077007 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 3 VIAL in 1 CARTON (84720-000-76) / 40 LOZENGE in 1 VIAL (84720-000-58)
source: ndc

Packages (1)

84720-000-76 3 VIAL in 1 CARTON (84720-000-76) / 40 LOZENGE in 1 VIAL (84720-000-58)

Ingredients (1)

nicotine (2 mg/1)

Linked Drug Pages (1)

quitine nicotine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a7e8138b-8884-4cc9-9827-2ecd07f11ffd", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0012345678905"], "unii": ["6M3C89ZY6R"], "rxcui": ["359817"], "spl_set_id": ["fd9ce0e2-b159-4e0d-a76e-7223d36810fb"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["QUITINE LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 VIAL in 1 CARTON (84720-000-76)  / 40 LOZENGE in 1 VIAL (84720-000-58)", "package_ndc": "84720-000-76", "marketing_start_date": "20241205"}], "brand_name": "quitine nicotine", "product_id": "84720-000_a7e8138b-8884-4cc9-9827-2ecd07f11ffd", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "84720-000", "generic_name": "Nicotine Polacrilex", "labeler_name": "QUITINE LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "quitine nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "2 mg/1"}], "application_number": "ANDA077007", "marketing_category": "ANDA", "marketing_start_date": "20241205", "listing_expiration_date": "20261231"}