nicotine

Generic: nicotine polacrilex

Labeler: meijer, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine
Generic Name nicotine polacrilex
Labeler meijer, inc.
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
Meijer, Inc.

Identifiers & Regulatory

Product NDC 79481-1100
Product ID 79481-1100_7ecd9a6a-1237-4375-b72c-9f2e30557650
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077007
Listing Expiration 2027-12-31
Marketing Start 2023-08-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 794811100
Hyphenated Format 79481-1100

Supplemental Identifiers

RxCUI
359818
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 ANDA077007 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 1 CONTAINER in 1 CARTON (79481-1100-0) / 20 LOZENGE in 1 CONTAINER
  • 2 CONTAINER in 1 CARTON (79481-1100-1) / 40 LOZENGE in 1 CONTAINER (79481-1100-2)
source: ndc

Packages (2)

79481-1100-0 1 CONTAINER in 1 CARTON (79481-1100-0) / 20 LOZENGE in 1 CONTAINER 79481-1100-1 2 CONTAINER in 1 CARTON (79481-1100-1) / 40 LOZENGE in 1 CONTAINER (79481-1100-2)

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": "7ecd9a6a-1237-4375-b72c-9f2e30557650", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["359818"], "spl_set_id": ["aee78555-7851-46a5-b9fa-c98b46354619"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Meijer, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CONTAINER in 1 CARTON (79481-1100-0)  / 20 LOZENGE in 1 CONTAINER", "package_ndc": "79481-1100-0", "marketing_start_date": "20230906"}, {"sample": false, "description": "2 CONTAINER in 1 CARTON (79481-1100-1)  / 40 LOZENGE in 1 CONTAINER (79481-1100-2)", "package_ndc": "79481-1100-1", "marketing_start_date": "20230823"}], "brand_name": "nicotine", "product_id": "79481-1100_7ecd9a6a-1237-4375-b72c-9f2e30557650", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "79481-1100", "generic_name": "nicotine polacrilex", "labeler_name": "Meijer, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA077007", "marketing_category": "ANDA", "marketing_start_date": "20230823", "listing_expiration_date": "20271231"}