Zolpidem Tartrate

Product NDC
55700-777
11-digit product format
557000777
Labeler code
55700
Product ID
55700-777_fb0008ce-c6a6-45f9-ad55-a67550b47d0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA078148
Marketing category
ANDA
Marketing start
2019-07-19
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-777-302025-01-10C16284748780-1f386c649-ef26-0266-e053-dadaa90a7c1a8e5435ba-6586-4a43-9cd2-99940ce7ad16
55700-777-302023-01-30C16284748780-1f386c649-ef26-0266-e053-dadaa90a7c1a8e5435ba-6586-4a43-9cd2-99940ce7ad16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-777-30EA - Each55700-7776302d76b-34c5-409b-a973-e698ac4d291f12019-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-777-305570007773030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-777-30) 2019-07-190000-00-00NoNoCurrent