rugby nicotine polacrilex gum, coated fruit flavor (0536-3387)

Drug Facts

Product Profile

Brand Name rugby nicotine polacrilex gum, coated fruit flavor

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 0536-3387

Product ID 0536-3387_c3233d63-7235-4d38-bea1-e0f2d0fe9cd1

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA079038

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 05363387

Hyphenated Format 0536-3387

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 rugby nicotine polacrilex gum, coated fruit flavor (source: ndc)

Generic Name nicotine polacrilex (source: ndc)

Application Number ANDA079038 (source: ndc)

Routes

BUCCAL

source: ndc

Resolved Composition

Strengths

4 mg/1

source: ndc

Packaging

10 BLISTER PACK in 1 CARTON (0536-3387-01) / 10 GUM, CHEWING in 1 BLISTER PACK

source: ndc

Packages (1)

0536-3387-01 10 BLISTER PACK in 1 CARTON (0536-3387-01) / 10 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["BUCCAL"], "spl_id": "c3233d63-7235-4d38-bea1-e0f2d0fe9cd1", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975", "314119"], "spl_set_id": ["b973d045-7791-49c1-9216-4e0d51173735"], "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": "10 BLISTER PACK in 1 CARTON (0536-3387-01)  / 10 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "0536-3387-01", "marketing_start_date": "20090708"}], "brand_name": "Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor", "product_id": "0536-3387_c3233d63-7235-4d38-bea1-e0f2d0fe9cd1", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "0536-3387", "generic_name": "Nicotine Polacrilex", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA079038", "marketing_category": "ANDA", "marketing_start_date": "20090708", "listing_expiration_date": "20271231"}