Zolpidem Tartrate

Product NDC
0228-3482
11-digit product format
002283482
Labeler code
0228
Product ID
0228-3482_3bb26b6e-1db9-4760-8668-6df7f6520da6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA078179
Marketing category
ANDA
Marketing start
2011-06-06
Marketing end
2020-07-31
Substance
ZOLPIDEM TARTRATE
Active strength
13 mg/1
Pharmacologic classes
gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-3482-11EA - Each0228-3482400786be-fedb-46ba-b092-65d39fda38e812012-07-24
0228-3482-50EA - Each0228-3482df645339-750e-4c4e-9969-ae61603b99a912012-07-24