FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
72789-390
11-digit product format
727890390
Labeler code
72789
Product ID
72789-390_2cefff0f-97f2-c4cb-e063-6394a90a0eba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078413
Marketing category
ANDA
Marketing start
2007-05-04
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
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
72789-390-21Zolpidem Tartrate21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2126
72789-390-30Zolpidem Tartrate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-390-21EA - Each72789-3900a460ce4-b6dc-4687-b50e-72f851fba0bd12024-05-16
72789-390-30EA - Each72789-390b84a73ac-7ec4-42ea-a32d-6a8322fdc1e412024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-390ZOLPIDEM TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]26Current NDC, 2 package rows20250131_38c838a4-9943-445a-8e80-e823d56eeaa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSN38c838a4-9943-445a-8e80-e823d56eeaa526
854876zolpidem tartrate 5 MG Oral TabletSCD38c838a4-9943-445a-8e80-e823d56eeaa526

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-390-217278903902121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-390-21) 2024-04-03NoNoCurrent
72789-390-307278903903030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-390-30) 2024-04-03NoNoCurrent