ZOLPIDEM TARTRATE

Product NDC
61919-751
11-digit product format
619190751
Labeler code
61919
Product ID
61919-751_47e15e5f-bc12-84ec-e063-6394a90a4bf0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZOLPIDEM TARTRATE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA077903
Marketing category
ANDA
Marketing start
2019-08-19
Substance
ZOLPIDEM TARTRATE
Active strength
5 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZOLPIDEM TARTRATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854876

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
61919-751-202022-03-01C16284748780-1d6a99b39-51cb-a426-e053-dadaa90af4c2ZOLPIDEM TARTRATE
61919-751-202022-01-28C16284748780-1d6a99b39-51cb-a426-e053-dadaa90af4c2ZOLPIDEM TARTRATE
61919-751-302020-01-31C16284748780-19d75b9d0-804d-f424-e053-dadaa90a57ceZOLPIDEM TARTRATE
61919-751-602020-01-31C16284748780-19d75b9d0-804d-f424-e053-dadaa90a57ceZOLPIDEM TARTRATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-751-10ZOLPIDEM TARTRATE10 in 1 BOTTLETABLET105
61919-751-20ZOLPIDEM TARTRATE20 in 1 BOTTLETABLET205
61919-751-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET302
61919-751-60ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-751-10EA - Each61919-751295f8fbb-9a58-414f-995a-3083203111af12022-04-06
61919-751-20EA - Each61919-751307216f9-907a-438f-81fd-6cec67e4ed6512019-09-05
61919-751-30EA - Each61919-751138efe1e-75ac-458a-ab04-c188b4b5028812016-06-14
61919-751-60EA - Each61919-751a9294292-2e5a-4d3b-8696-5438b5b2caa712016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [DIRECTRX]2
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [DIRECTRX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [DIRECTRX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-751ZOLPIDEM TARTRATE TABLET [DIRECT_RX]4Current NDC, Legacy NDC, 2 package rows20240111_907c7b18-2638-512c-e053-2995a90ae6fd.zip
61919-751ZOLPIDEM TARTRATE TABLET [DIRECTRX]2Current NDC, Legacy NDC, 2 package rows20151112_68062bb7-ef75-4540-b6c0-26bc57a80f67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSN907c7b18-2638-512c-e053-2995a90ae6fd5
854876zolpidem tartrate 5 MG Oral TabletSCD907c7b18-2638-512c-e053-2995a90ae6fd5
854876zolpidem tartrate 5 MG Oral TabletPSN68062bb7-ef75-4540-b6c0-26bc57a80f672
854876zolpidem tartrate 5 MG Oral TabletSCD68062bb7-ef75-4540-b6c0-26bc57a80f672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-751-106191907511010 TABLET in 1 BOTTLE (61919-751-10) 10 tablet2019-08-190000-00-00NoNoCurrent
61919-751-206191907512020 TABLET in 1 BOTTLE (61919-751-20) 20 tablet2019-08-190000-00-00NoNoCurrent
61919-751-306191907513030 in 1 BOTTLEHistorical
61919-751-606191907516060 in 1 BOTTLEHistorical