FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
63187-707
11-digit product format
631870707
Labeler code
63187
Product ID
63187-707_f8dfb619-9219-4973-9362-f6a32ecac185
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076410
Marketing category
ANDA
Marketing start
2007-04-23
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-707-15Zolpidem Tartrate15 in 1 BOTTLETABLET, FILM COATED154
63187-707-30Zolpidem Tartrate30 in 1 BOTTLETABLET, FILM COATED304
63187-707-60Zolpidem Tartrate60 in 1 BOTTLETABLET, FILM COATED604
63187-707-90Zolpidem Tartrate90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-707-60EA - Each63187-707f03310ee-b50b-4378-941e-616418e018f812016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-707ZOLPIDEM TARTRATE TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20191121_e8572fd4-70c7-4c94-a0d7-9b4be6fa8f77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSNe8572fd4-70c7-4c94-a0d7-9b4be6fa8f774
854876zolpidem tartrate 5 MG Oral TabletSCDe8572fd4-70c7-4c94-a0d7-9b4be6fa8f774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-707-156318707071515 TABLET, FILM COATED in 1 BOTTLE (63187-707-15) 2016-06-010000-00-00NoNoCurrent
63187-707-306318707073030 TABLET, FILM COATED in 1 BOTTLE (63187-707-30) 2016-06-010000-00-00NoNoCurrent
63187-707-606318707076060 TABLET, FILM COATED in 1 BOTTLE (63187-707-60) 2016-06-010000-00-00NoNoCurrent
63187-707-906318707079090 TABLET, FILM COATED in 1 BOTTLE (63187-707-90) 2016-06-010000-00-00NoNoCurrent