Zolpidem Tartrate

Product NDC
68084-523
11-digit product format
680840523
Labeler code
68084
Product ID
68084-523_75b2bc5f-7031-fa9d-e053-2a91aa0ab73d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078179
Marketing category
ANDA
Marketing start
2011-11-22
Marketing end
2019-05-31
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
68084-523-11EA - Each68084-523a4f6a66e-a1e9-4e6b-807d-0d179160d1d912012-07-24
68084-523-21EA - Each68084-52358ee3ee2-8e12-4a97-9399-7ed44ee8338512012-07-24