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NDC 68180-0780-02 ZOLPIDEM TARTRATE 12.5 mg/1 Details

ZOLPIDEM TARTRATE 12.5 mg/1

ZOLPIDEM TARTRATE is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is ZOLPIDEM TARTRATE.

MedlinePlus Drug Summary

Zolpidem is used to treat insomnia (difficulty falling asleep or staying asleep). Zolpidem belongs to a class of medications called sedative-hypnotics. It works by slowing activity in the brain to allow sleep.

Related Packages: 68180-0780-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Zolpidem

Product Information

NDC	68180-0780
Product ID	68180-780_0b0d439e-9812-4697-a98b-023eb50fb972
Associated GPIs	60204080100420
GCN Sequence Number	059697
GCN Sequence Number Description	zolpidem tartrate TAB MPHASE 12.5 MG ORAL
HIC3	H2E
HIC3 Description	SEDATIVE-HYPNOTICS,NON-BARBITURATE
GCN	25457
HICL Sequence Number	007842
HICL Sequence Number Description	ZOLPIDEM TARTRATE
Brand/Generic	Generic
Proprietary Name	ZOLPIDEM TARTRATE
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zolpidem Tartrate
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	12.5
Active Ingredient Units	mg/1
Substance Name	ZOLPIDEM TARTRATE
Labeler Name	Lupin Pharmaceuticals, Inc.
Pharmaceutical Class	Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA Schedule	CIV
Marketing Category	ANDA
Application Number	ANDA078970
Listing Certified Through	2025-12-31

Package

NDC 68180-0780-02 (68180078002)

Pricing Information	N/A
NDC Package Code	68180-780-02
Billing NDC	68180078002
Package	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-780-02)
Marketing Start Date	2014-04-11
NDC Exclude Flag	N