nicotine polacrilex

Generic: nicotine polacrilex

Labeler: rugby laboratories
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine polacrilex
Generic Name nicotine polacrilex
Labeler rugby laboratories
Dosage Form GUM, CHEWING
Routes
BUCCAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-3405
Product ID 0536-3405_05d9e501-7456-414d-ae98-ffe06a88d576
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079219
Listing Expiration 2027-12-31
Marketing Start 2009-07-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05363405
Hyphenated Format 0536-3405

Supplemental Identifiers

RxCUI
311975 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 nicotine polacrilex (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA079219 (source: ndc)
Routes
BUCCAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0536-3405-01) / 1 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (1)

0536-3405-01 100 BLISTER PACK in 1 CARTON (0536-3405-01) / 1 GUM, CHEWING in 1 BLISTER PACK

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": ["BUCCAL"], "spl_id": "05d9e501-7456-414d-ae98-ffe06a88d576", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975", "314119"], "spl_set_id": ["d67149d5-4766-4b84-8205-f1a6b692f4c9"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Rugby Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0536-3405-01)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "0536-3405-01", "marketing_start_date": "20090708"}], "brand_name": "Nicotine Polacrilex", "product_id": "0536-3405_05d9e501-7456-414d-ae98-ffe06a88d576", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "0536-3405", "generic_name": "Nicotine Polacrilex", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine Polacrilex", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA079219", "marketing_category": "ANDA", "marketing_start_date": "20090708", "listing_expiration_date": "20271231"}