ZOLPIDEM TARTRATE

Product NDC
68788-7688
11-digit product format
687887688
Labeler code
68788
Product ID
68788-7688_e3538792-4e97-430d-90cc-93a5a36615e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA078970
Marketing category
ANDA
Marketing start
2020-04-01
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
6 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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7688-2EA - Each68788-76880ec2ba76-2c3e-4ef1-9f0a-73e04da5243e12020-07-13
68788-7688-3EA - Each68788-768834a6e0fe-5849-41af-9dc3-d9dce1609d0312020-07-13
68788-7688-6EA - Each68788-76889d5fcf29-343e-4a75-932f-4fd17d066b1412020-07-13
68788-7688-9EA - Each68788-76886d6d15e1-4c95-4264-bdb9-7c9507e44e5712020-07-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7688-26878876880228 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7688-2) 2020-04-010000-00-00NoNoCurrent
68788-7688-36878876880330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7688-3) 2020-04-010000-00-00NoNoCurrent
68788-7688-66878876880660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7688-6) 2020-04-010000-00-00NoNoCurrent
68788-7688-96878876880990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7688-9) 2020-04-010000-00-00NoNoCurrent