nicotine

Generic: nicotine polacrilex

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

Drug Facts

Product Profile

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

nicotine 2 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-903
Product ID 58602-903_dcc0b057-3d5e-4aeb-ac31-478d7a2f47fa
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213266
Listing Expiration 2026-12-31
Marketing Start 2022-06-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602903
Hyphenated Format 58602-903

Supplemental Identifiers

RxCUI
359817
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 (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA213266 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 1 CONTAINER in 1 CARTON (58602-903-07) / 24 LOZENGE in 1 CONTAINER
  • 3 CONTAINER in 1 CARTON (58602-903-51) / 24 LOZENGE in 1 CONTAINER
  • 6 CONTAINER in 1 CARTON (58602-903-65) / 24 LOZENGE in 1 CONTAINER
source: ndc

Packages (3)

58602-903-07 1 CONTAINER in 1 CARTON (58602-903-07) / 24 LOZENGE in 1 CONTAINER 58602-903-51 3 CONTAINER in 1 CARTON (58602-903-51) / 24 LOZENGE in 1 CONTAINER 58602-903-65 6 CONTAINER in 1 CARTON (58602-903-65) / 24 LOZENGE in 1 CONTAINER

Ingredients (1)

nicotine (2 mg/1)

Linked Drug Pages (1)

NICOTINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dcc0b057-3d5e-4aeb-ac31-478d7a2f47fa", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["359817"], "spl_set_id": ["dcc0b057-3d5e-4aeb-ac31-478d7a2f47fa"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CONTAINER in 1 CARTON (58602-903-07)  / 24 LOZENGE in 1 CONTAINER", "package_ndc": "58602-903-07", "marketing_start_date": "20220624"}, {"sample": false, "description": "3 CONTAINER in 1 CARTON (58602-903-51)  / 24 LOZENGE in 1 CONTAINER", "package_ndc": "58602-903-51", "marketing_start_date": "20220624"}, {"sample": false, "description": "6 CONTAINER in 1 CARTON (58602-903-65)  / 24 LOZENGE in 1 CONTAINER", "package_ndc": "58602-903-65", "marketing_start_date": "20220624"}], "brand_name": "NICOTINE", "product_id": "58602-903_dcc0b057-3d5e-4aeb-ac31-478d7a2f47fa", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "58602-903", "generic_name": "NICOTINE POLACRILEX", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NICOTINE", "active_ingredients": [{"name": "NICOTINE", "strength": "2 mg/1"}], "application_number": "ANDA213266", "marketing_category": "ANDA", "marketing_start_date": "20220624", "listing_expiration_date": "20261231"}