FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
63187-690
11-digit product format
631870690
Labeler code
63187
Product ID
63187-690_a82182c3-c3b7-4ecb-a223-a921e24cce66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077322
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 Tartrate
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
63187-690-15Zolpidem Tartrate15 in 1 BOTTLETABLET, COATED154
63187-690-30Zolpidem Tartrate30 in 1 BOTTLETABLET, COATED304
63187-690-60Zolpidem Tartrate60 in 1 BOTTLETABLET, COATED604
63187-690-90Zolpidem Tartrate90 in 1 BOTTLETABLET, COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-690ZOLPIDEM TARTRATE TABLET, COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20210112_92c58053-7ed8-4a3d-a2f7-8e30c4e5a367.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN92c58053-7ed8-4a3d-a2f7-8e30c4e5a3674
854876zolpidem tartrate 5 MG Oral TabletPSN92c58053-7ed8-4a3d-a2f7-8e30c4e5a3674
854873zolpidem tartrate 10 MG Oral TabletSCD92c58053-7ed8-4a3d-a2f7-8e30c4e5a3674
854876zolpidem tartrate 5 MG Oral TabletSCD92c58053-7ed8-4a3d-a2f7-8e30c4e5a3674

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-690-156318706901515 TABLET, COATED in 1 BOTTLE (63187-690-15) 2016-04-010000-00-00NoNoCurrent
63187-690-306318706903030 TABLET, COATED in 1 BOTTLE (63187-690-30) 2016-04-010000-00-00NoNoCurrent
63187-690-606318706906060 TABLET, COATED in 1 BOTTLE (63187-690-60) 2016-04-010000-00-00NoNoCurrent
63187-690-906318706909090 TABLET, COATED in 1 BOTTLE (63187-690-90) 2016-04-010000-00-00NoNoCurrent