nicotine polacrilex original

Generic: nicotine polacrilex

Labeler: cardinal health (leader) 70000
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine polacrilex original
Generic Name nicotine polacrilex
Labeler cardinal health (leader) 70000
Dosage Form GUM, CHEWING
Routes
BUCCAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
Cardinal Health (Leader) 70000

Identifiers & Regulatory

Product NDC 70000-0341
Product ID 70000-0341_867fc3f8-ad64-473a-8dc0-885bf0e4d90e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074707
Listing Expiration 2026-12-31
Marketing Start 2018-07-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000341
Hyphenated Format 70000-0341

Supplemental Identifiers

RxCUI
311975 314119
UPC
0096295133837 0096295133844
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 original (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA074707 (source: ndc)
Routes
BUCCAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (70000-0341-1) / 1 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (1)

70000-0341-1 50 BLISTER PACK in 1 CARTON (70000-0341-1) / 1 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Nicotine Polacrilex Original ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["BUCCAL"], "spl_id": "867fc3f8-ad64-473a-8dc0-885bf0e4d90e", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0096295133837", "0096295133844"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975", "314119"], "spl_set_id": ["4acbda22-9c87-49f2-ad5f-55b1e54bdf2e"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Cardinal Health (Leader) 70000"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (70000-0341-1)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "70000-0341-1", "marketing_start_date": "20180703"}], "brand_name": "Nicotine Polacrilex Original", "product_id": "70000-0341_867fc3f8-ad64-473a-8dc0-885bf0e4d90e", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "70000-0341", "generic_name": "Nicotine Polacrilex", "labeler_name": "Cardinal Health (Leader) 70000", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine Polacrilex", "brand_name_suffix": "Original", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA074707", "marketing_category": "ANDA", "marketing_start_date": "20180703", "listing_expiration_date": "20261231"}