careone nicotine

Generic: nicotine polacrilex

Labeler: american sales company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name careone nicotine
Generic Name nicotine polacrilex
Labeler american sales company
Dosage Form GUM, CHEWING
Routes
ORAL
Active Ingredients

nicotine 2 mg/1

Manufacturer
American Sales Company

Identifiers & Regulatory

Product NDC 41520-792
Product ID 41520-792_a4253916-0b80-46c3-8660-d3924b327bc7
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076775
Listing Expiration 2026-12-31
Marketing Start 2017-11-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 41520792
Hyphenated Format 41520-792

Supplemental Identifiers

RxCUI
314119
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 careone nicotine (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA076775 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 110 BLISTER PACK in 1 CARTON (41520-792-25) / 1 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (1)

41520-792-25 110 BLISTER PACK in 1 CARTON (41520-792-25) / 1 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (2 mg/1)

Linked Drug Pages (1)

CareOne nicotine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a4253916-0b80-46c3-8660-d3924b327bc7", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["314119"], "spl_set_id": ["ffaa553c-7323-4d9c-87f4-2846bc51fa7c"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["American Sales Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "110 BLISTER PACK in 1 CARTON (41520-792-25)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "41520-792-25", "marketing_start_date": "20171113"}], "brand_name": "CareOne nicotine", "product_id": "41520-792_a4253916-0b80-46c3-8660-d3924b327bc7", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "41520-792", "generic_name": "Nicotine Polacrilex", "labeler_name": "American Sales Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CareOne nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "2 mg/1"}], "application_number": "ANDA076775", "marketing_category": "ANDA", "marketing_start_date": "20171113", "listing_expiration_date": "20261231"}