nicotine polacrilex

Generic: nicotine polacrilex

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

Drug Facts

Product Profile

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

nicotine 4 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3957
Product ID 68071-3957_49617fc9-4948-7bab-e063-6294a90afcbb
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077007
Listing Expiration 2027-12-31
Marketing Start 2014-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713957
Hyphenated Format 68071-3957

Supplemental Identifiers

RxCUI
359818
UPC
0012345678905 0368071395778
UNII
6M3C89ZY6R
NUI
N0000175706 M0014836

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 polacrilex (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
  • 3 CONTAINER in 1 CARTON (68071-3957-7) / 72 LOZENGE in 1 CONTAINER
source: ndc

Packages (1)

68071-3957-7 3 CONTAINER in 1 CARTON (68071-3957-7) / 72 LOZENGE in 1 CONTAINER

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Nicotine Polacrilex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "49617fc9-4948-7bab-e063-6294a90afcbb", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0012345678905", "0368071395778"], "unii": ["6M3C89ZY6R"], "rxcui": ["359818"], "spl_set_id": ["49125b9b-8ccd-b122-e063-6394a90a483c"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 CONTAINER in 1 CARTON (68071-3957-7)  / 72 LOZENGE in 1 CONTAINER", "package_ndc": "68071-3957-7", "marketing_start_date": "20260123"}], "brand_name": "Nicotine Polacrilex", "product_id": "68071-3957_49617fc9-4948-7bab-e063-6294a90afcbb", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "68071-3957", "generic_name": "Nicotine Polacrilex", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine Polacrilex", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA077007", "marketing_category": "ANDA", "marketing_start_date": "20140331", "listing_expiration_date": "20271231"}