Zolpidem Tartrate

Product NDC
68788-7407
11-digit product format
687887407
Labeler code
68788
Product ID
68788-7407_267029ca-f29c-4455-8ef1-0dce36ac9397
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
NDA021774
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-06-06
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
68788-7407-2EA - Each68788-7407f3ba7e48-4150-4b86-a2d5-7491aa5cd52a12018-08-13
68788-7407-3EA - Each68788-74077a043f46-9c16-4f0d-9056-c2c8c43c72aa12018-08-13
68788-7407-6EA - Each68788-7407f6a51285-e4b4-4f46-8595-fa5c3ccc37f912018-08-13
68788-7407-9EA - Each68788-74074af0ca33-f552-41ba-b604-5584b36ce18112018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7407-26878874070228 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7407-2) 2018-06-060000-00-00NoNoCurrent
68788-7407-36878874070330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7407-3) 2018-06-060000-00-00NoNoCurrent
68788-7407-66878874070660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7407-6) 2018-06-060000-00-00NoNoCurrent
68788-7407-96878874070990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7407-9) 2018-06-060000-00-00NoNoCurrent