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NDC 36800-0456-78 Topcare Nicotine 2 mg/1 Details

Topcare Nicotine 2 mg/1

Topcare Nicotine is a ORAL GUM, CHEWING in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is NICOTINE.

MedlinePlus Drug Summary

Nicotine chewing gum is used to help people stop smoking cigarettes. Nicotine chewing gum should be used together with a smoking cessation program, which may include support groups, counseling, or specific behavioral change techniques. Nicotine gum is in a class of medications called smoking cessation aids. It works by providing nicotine to your body to decrease the withdrawal symptoms experienced when smoking is stopped and as a substitute oral activity to reduce the urge to smoke.

Related Packages: 36800-0456-78
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nicotine Gum

Product Information

NDC	36800-0456
Product ID	36800-456_c8071997-8c37-46f7-bba4-8495b8d53d32
Associated GPIs	62100010002810
GCN Sequence Number	004930
GCN Sequence Number Description	nicotine polacrilex GUM 2 MG BUCCAL
HIC3	J3A
HIC3 Description	SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS)
GCN	03200
HICL Sequence Number	002049
HICL Sequence Number Description	NICOTINE POLACRILEX
Brand/Generic	Generic
Proprietary Name	Topcare Nicotine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Nicotine Polacrilex
Product Type	HUMAN OTC DRUG
Dosage Form	GUM, CHEWING
Route	ORAL
Active Ingredient Strength	2
Active Ingredient Units	mg/1
Substance Name	NICOTINE
Labeler Name	Topco Associates LLC
Pharmaceutical Class	Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076777
Listing Certified Through	2024-12-31

Package

NDC 36800-0456-78 (36800045678)

Pricing Information	N/A
NDC Package Code	36800-456-78
Billing NDC	36800045678
Package	100 BLISTER PACK in 1 CARTON (36800-456-78) / 1 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date	2006-12-18
NDC Exclude Flag	N