Zolpidem

Product NDC: 72162-1982
11-digit product format: 721621982
Labeler code: 72162
Product ID: 72162-1982_2ff1da74-bb60-4476-a2c4-088373b8f83b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zolpidem Tartrate
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077214
Marketing category: ANDA
Marketing start: 2020-09-24
Substance: ZOLPIDEM TARTRATE
Active strength: 5 mg/1
Pharmacologic classes: Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 72162-1982_2ff1da74-bb60-4476-a2c4-088373b8f83b
SPL ID: 2ff1da74-bb60-4476-a2c4-088373b8f83b
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Zolpidem
Generic name: Zolpidem Tartrate
Dosage form: TABLET
Route: ORAL
Marketing start: 2020-09-24
Marketing category: ANDA
Application number: ANDA077214
Pharmacologic classes: Central Nervous System Depression [PE]; GABA A Agonists [MoA]; Pyridines [CS]; gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA schedule: CIV
Listing expiration: 2026-12-31

Ingredient	Strength
ZOLPIDEM TARTRATE	5 mg/1

Package NDC	Description	Marketing start	Sample
72162-1982-1	100 TABLET in 1 BOTTLE (72162-1982-1)	2023-12-05	No

UNII	Preferred term	Registry number	Matched term
WY6W63843K	ZOLPIDEM TARTRATE	99294-93-6	ZOLPIDEM TARTRATE

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-1982-1	72162198201	100 TABLET in 1 BOTTLE (72162-1982-1)	100 tablet	2023-12-05	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Zolpidem	Bryant Ranch Prepack	2023-12-27	HUMAN PRESCRIPTION DRUG LABEL	101