nicotine

Generic: nicotine polacrilex

Labeler: p & l development, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine
Generic Name nicotine polacrilex
Labeler p & l development, llc
Dosage Form GUM, CHEWING
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
P & L Development, LLC

Identifiers & Regulatory

Product NDC 59726-935
Product ID 59726-935_dff0c459-55dd-4c0d-bf28-ca3f833db79c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074707
Listing Expiration 2027-12-31
Marketing Start 2024-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59726935
Hyphenated Format 59726-935

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 (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA074707 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 170 BLISTER PACK in 1 CARTON (59726-935-17) / 1 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (1)

59726-935-17 170 BLISTER PACK in 1 CARTON (59726-935-17) / 1 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (4 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": "dff0c459-55dd-4c0d-bf28-ca3f833db79c", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975"], "spl_set_id": ["4d669f54-5031-4b89-a546-6cdefc648fc3"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["P & L Development, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "170 BLISTER PACK in 1 CARTON (59726-935-17)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "59726-935-17", "marketing_start_date": "20240301"}], "brand_name": "Nicotine", "product_id": "59726-935_dff0c459-55dd-4c0d-bf28-ca3f833db79c", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "59726-935", "generic_name": "nicotine polacrilex", "labeler_name": "P & L Development, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA074707", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20271231"}