rugby nicotine polacrilex gum, original flavor

Generic: nicotine polacrilex

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

Drug Facts

Product Profile

Brand Name rugby nicotine polacrilex gum, original 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 0536-3030
Product ID 0536-3030_a7fad73a-749d-4287-b756-2cd203b85d35
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074707
Listing Expiration 2027-12-31
Marketing Start 1999-03-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05363030
Hyphenated Format 0536-3030

Supplemental Identifiers

RxCUI
311975 314119
UPC
0305363029348 0305363030061
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, original flavor (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
  • 5 BLISTER PACK in 1 CARTON (0536-3030-06) / 10 GUM, CHEWING in 1 BLISTER PACK
  • 11 BLISTER PACK in 1 CARTON (0536-3030-23) / 10 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (2)

0536-3030-06 5 BLISTER PACK in 1 CARTON (0536-3030-06) / 10 GUM, CHEWING in 1 BLISTER PACK 0536-3030-23 11 BLISTER PACK in 1 CARTON (0536-3030-23) / 10 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["BUCCAL"], "spl_id": "a7fad73a-749d-4287-b756-2cd203b85d35", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0305363029348", "0305363030061"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975", "314119"], "spl_set_id": ["1fc88637-4329-486e-82ab-19eeb06080a6"], "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": "5 BLISTER PACK in 1 CARTON (0536-3030-06)  / 10 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "0536-3030-06", "marketing_start_date": "19990319"}, {"sample": false, "description": "11 BLISTER PACK in 1 CARTON (0536-3030-23)  / 10 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "0536-3030-23", "marketing_start_date": "19990319"}], "brand_name": "Rugby Nicotine Polacrilex Gum, Original Flavor", "product_id": "0536-3030_a7fad73a-749d-4287-b756-2cd203b85d35", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "0536-3030", "generic_name": "Nicotine Polacrilex", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Rugby Nicotine Polacrilex Gum, Original Flavor", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA074707", "marketing_category": "ANDA", "marketing_start_date": "19990319", "listing_expiration_date": "20271231"}