"51991-982-01" National Drug Code (NDC)

Zolpidem Tartrate 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-982-01)
(Breckenridge Pharmaceutical, Inc.)

NDC Code51991-982-01
Package Description100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-982-01)
Product NDC51991-982
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameZolpidem Tartrate
Non-Proprietary NameZolpidem Tartrate
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20260301
Marketing Category NameANDA
Application NumberANDA213592
ManufacturerBreckenridge Pharmaceutical, Inc.
Substance NameZOLPIDEM TARTRATE
Strength12.5
Strength Unitmg/1
Pharmacy ClassesCentral Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
DEA ScheduleCIV

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