Zolpidem Tartrate

Product NDC
67296-1591
11-digit product format
672961591
Labeler code
67296
Product ID
67296-1591_d61c28e6-9c53-12db-e053-2a95a90a4e97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA076410
Marketing category
ANDA
Marketing start
2018-01-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1591-62024-01-30C16284748780-11030e365-66b3-111a-e063-dadaa90a10e2zolpidem

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1591-6Zolpidem Tartrate6 in 1 BOTTLETABLET, FILM COATED63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1591ZOLPIDEM TARTRATE TABLET, FILM COATED [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20220122_6a123164-e688-5ce3-e053-2a91aa0a76bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSN6a123164-e688-5ce3-e053-2a91aa0a76bc3
854876zolpidem tartrate 5 MG Oral TabletSCD6a123164-e688-5ce3-e053-2a91aa0a76bc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1591-6672961591066 TABLET, FILM COATED in 1 BOTTLE (67296-1591-6) 2018-01-010000-00-00NoNoCurrent