ZOLPIDEM TARTRATE

Product NDC
43063-652
11-digit product format
430630652
Labeler code
43063
Product ID
43063-652_e5f86dc1-a7ba-10f2-e053-2a95a90a2c0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
5 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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75543837-e611-4401-8337-81e7d5cb9b04Product name120231011
f40c5cae-52e4-45d3-95e3-8ba7f79e50e4Product name320201208
70793b8c-c4d9-ddb4-5f8a-4308eb0087a2Product name420171109
3970acdc-9e18-4f3d-165e-245802aafc57Product name220160829
438b1497-0992-6caa-062f-3853a7f9e4b1Product name120140508
813c8976-a1f1-3a35-1a71-1557bfb59446Product name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-652ZOLPIDEM TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]32Legacy NDC20240925_29f3d258-c152-6880-e054-00144ff88e88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-652-02430630652022 TABLET in 1 BOTTLE, PLASTIC (43063-652-02) 2 tablet2016-01-280000-00-00NoNoCurrent
43063-652-104306306521010 TABLET in 1 BOTTLE, PLASTIC (43063-652-10) 10 tablet2016-01-250000-00-00NoNoCurrent
43063-652-144306306521414 TABLET in 1 BOTTLE, PLASTIC (43063-652-14) 14 tablet2016-06-160000-00-00NoNoCurrent
43063-652-214306306522121 TABLET in 1 BOTTLE, PLASTIC (43063-652-21) 21 tablet2021-03-170000-00-00NoNoCurrent
43063-652-304306306523030 TABLET in 1 BOTTLE, PLASTIC (43063-652-30) 30 tablet2016-08-010000-00-00NoNoCurrent
43063-652-604306306526060 TABLET in 1 BOTTLE, PLASTIC (43063-652-60) 60 tablet2016-05-200000-00-00NoNoCurrent
43063-652-79430630652791 TABLET in 1 BOTTLE, PLASTIC (43063-652-79) 1 tablet2016-02-170000-00-00NoNoCurrent