nicorette

Generic: nicotine polacrilex

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicorette
Generic Name nicotine polacrilex
Labeler haleon us holdings llc
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 2 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-0635
Product ID 0135-0635_fd080df4-10ba-4b7e-a999-474f51610d2a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077007
Listing Expiration 2026-12-31
Marketing Start 2022-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01350635
Hyphenated Format 0135-0635

Supplemental Identifiers

RxCUI
359817 359818 968849 968851
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 nicorette (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 CONTAINER in 1 CARTON (0135-0635-01) / 72 LOZENGE in 1 CONTAINER
  • 6 CONTAINER in 1 CARTON (0135-0635-02) / 144 LOZENGE in 1 CONTAINER
source: ndc

Packages (2)

0135-0635-01 3 CONTAINER in 1 CARTON (0135-0635-01) / 72 LOZENGE in 1 CONTAINER 0135-0635-02 6 CONTAINER in 1 CARTON (0135-0635-02) / 144 LOZENGE in 1 CONTAINER

Ingredients (1)

nicotine (2 mg/1)

Linked Drug Pages (1)

NICORETTE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fd080df4-10ba-4b7e-a999-474f51610d2a", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["359817", "359818", "968849", "968851"], "spl_set_id": ["ffeb8286-860d-49f5-8df3-724afb4aaad8"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 CONTAINER in 1 CARTON (0135-0635-01)  / 72 LOZENGE in 1 CONTAINER", "package_ndc": "0135-0635-01", "marketing_start_date": "20220601"}, {"sample": false, "description": "6 CONTAINER in 1 CARTON (0135-0635-02)  / 144 LOZENGE in 1 CONTAINER", "package_ndc": "0135-0635-02", "marketing_end_date": "20260430", "marketing_start_date": "20220601"}], "brand_name": "NICORETTE", "product_id": "0135-0635_fd080df4-10ba-4b7e-a999-474f51610d2a", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "0135-0635", "generic_name": "nicotine polacrilex", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NICORETTE", "active_ingredients": [{"name": "NICOTINE", "strength": "2 mg/1"}], "application_number": "ANDA077007", "marketing_category": "ANDA", "marketing_start_date": "20220601", "listing_expiration_date": "20261231"}