FDA.reportPublic FDA data

Zolpidem

Product NDC
51407-878
11-digit product format
514070878
Labeler code
51407
Product ID
51407-878_1df27557-91ea-94f6-e063-6294a90aef8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA077214
Marketing category
ANDA
Marketing start
2007-04-23
Substance
ZOLPIDEM TARTRATE
Active strength
10 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zolpidem
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLPIDEM TARTRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854873, 854876

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-878-01Zolpidem100 in 1 BOTTLETABLET1002
51407-878-10Zolpidem1000 in 1 BOTTLETABLET10002
51407-878-30Zolpidem30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-878-01EA - Each51407-8780e8a0784-7693-4c29-a2c0-75fa59fa357812024-07-12
51407-878-10EA - Each51407-878b2af7613-0d79-43d7-99a1-f908ffebb12b12024-07-12
51407-878-30EA - Each51407-87881a32ac3-d9b7-4ad3-904e-7086d44e70b412024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-878ZOLPIDEM (ZOLPIDEM TARTRATE) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2Current NDC, 3 package rows20240724_1a8f7696-0d02-dd1f-e063-6394a90a5866.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN1e15d6e3-8d06-0936-e063-6394a90ab8db6
854873zolpidem tartrate 10 MG Oral TabletSCD1e15d6e3-8d06-0936-e063-6394a90ab8db6
854873zolpidem tartrate 10 MG Oral TabletPSN1a8f7696-0d02-dd1f-e063-6394a90a58662
854876zolpidem tartrate 5 MG Oral TabletPSN1a8f7696-0d02-dd1f-e063-6394a90a58662
854873zolpidem tartrate 10 MG Oral TabletSCD1a8f7696-0d02-dd1f-e063-6394a90a58662
854876zolpidem tartrate 5 MG Oral TabletSCD1a8f7696-0d02-dd1f-e063-6394a90a58662

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-878-0151407087801100 TABLET in 1 BOTTLE (51407-878-01) 100 tablet2024-05-17NoNoHistorical
51407-878-10514070878101000 TABLET in 1 BOTTLE (51407-878-10) 1000 tablet2024-05-17NoNoHistorical
51407-878-305140708783030 TABLET in 1 BOTTLE (51407-878-30) 30 tablet2024-05-17NoNoHistorical