Zaleplon

Product NDC
71335-2468
11-digit product format
713352468
Labeler code
71335
Product ID
71335-2468_5cbad0f1-c66b-4bd0-bfb0-530333c5e4d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zaleplon
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090374
Marketing category
ANDA
Marketing start
2024-02-17
Substance
ZALEPLON
Active strength
10 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Agonists [MoA], gamma-Aminobutyric Acid A Receptor Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
S62U433RMHZALEPLON151319-34-5ZALEPLON

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2468-17133524680115 CAPSULE in 1 BOTTLE (71335-2468-1) 15 capsule2024-08-16NoNoHistorical
71335-2468-27133524680230 CAPSULE in 1 BOTTLE (71335-2468-2) 30 capsule2024-08-16NoNoHistorical
71335-2468-37133524680360 CAPSULE in 1 BOTTLE (71335-2468-3) 60 capsule2024-08-16NoNoHistorical
71335-2468-47133524680490 CAPSULE in 1 BOTTLE (71335-2468-4) 90 capsule2024-08-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Zaleplon Capsules , USP CIVBryant Ranch Prepack2024-08-16HUMAN PRESCRIPTION DRUG LABEL2