NDC 50436-0009

Zolpidem

Zolpidem Tartrate

Zolpidem is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Unit Dose Services. The primary component is Zolpidem Tartrate.

Product ID50436-0009_2cb7ecc0-7d4c-487f-bc74-43e912ca4283
NDC50436-0009
Product TypeHuman Prescription Drug
Proprietary NameZolpidem
Generic NameZolpidem Tartrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-09-24
Marketing CategoryANDA /
Application NumberANDA077214
Labeler NameUnit Dose Services
Substance NameZOLPIDEM TARTRATE
Active Ingredient Strength5 mg/1
Pharm ClassesCentral Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50436-0009-1

30 TABLET in 1 BOTTLE (50436-0009-1)
Marketing Start Date2022-03-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Zolpidem" or generic name "Zolpidem Tartrate"

NDCBrand NameGeneric Name
0143-9962ZolpidemZolpidem
0143-9963ZolpidemZolpidem
71093-156ZolpidemZolpidem
71093-155ZolpidemZolpidem
63629-1170ZolpidemZolpidem
63629-1171ZolpidemZolpidem
0024-5401Ambienzolpidem tartrate
0024-5421Ambienzolpidem tartrate
0024-5501Ambienzolpidem tartrate
0024-5521Ambienzolpidem tartrate
0037-6010EdluarZolpidem Tartrate
0037-6050EdluarZolpidem Tartrate
0054-0086Zolpidem Tartratezolpidem tartrate
0054-0087Zolpidem Tartratezolpidem tartrate
0093-0073Zolpidem TartrateZolpidem Tartrate
0093-0074Zolpidem TartrateZolpidem Tartrate

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.