Zolpidem tartrate

Product NDC
68788-7903
11-digit product format
687887903
Labeler code
68788
Product ID
68788-7903_017da303-9b20-46ab-9a39-3894ec141c72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090107
Marketing category
ANDA
Marketing start
2021-05-14
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
6 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7903-3EA - Each68788-7903d46234ff-9ead-404f-a2ae-522846359f7112021-07-15
68788-7903-6EA - Each68788-79035c2255e8-7082-4980-888f-9cc2795eb83f12021-07-15
68788-7903-9EA - Each68788-79032b8c6fbc-3a60-4a81-a731-17298bad3d8d12021-07-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7903-36878879030330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7903-3) 2021-05-140000-00-00NoNoCurrent
68788-7903-66878879030660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7903-6) 2021-05-140000-00-00NoNoCurrent
68788-7903-96878879030990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7903-9) 2021-05-140000-00-00NoNoCurrent