FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
72789-323
11-digit product format
727890323
Labeler code
72789
Product ID
72789-323_2c50fde4-3d33-4137-e063-6394a90a73d6
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
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

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
72789-323-01Zolpidem Tartrate100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10030
72789-323-10Zolpidem Tartrate10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1030
72789-323-14Zolpidem Tartrate14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1430
72789-323-15Zolpidem Tartrate15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1530
72789-323-21Zolpidem Tartrate21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2130
72789-323-30Zolpidem Tartrate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3030
72789-323-60Zolpidem Tartrate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-323-01EA - Each72789-323498f5437-a73c-4d4b-a598-0022f0a5647712023-07-06
72789-323-10EA - Each72789-323b784580b-bf90-4ec3-90d1-023dcd2caf1312023-12-05
72789-323-14EA - Each72789-323fe291195-6720-47c5-88fc-33e9fe0814a612024-03-12
72789-323-21EA - Each72789-3231fabfa48-319e-43bf-8c61-76f36122a0d012024-01-04
72789-323-30EA - Each72789-32344bc507f-a0ed-4279-9507-69b4df47c8c812023-07-06
72789-323-60EA - Each72789-32369713754-c70e-4c59-ae30-e9005245e3a412023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-323ZOLPIDEM TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]30Current NDC, 7 package rows20250124_fda413e7-b1ae-312a-e053-6394a90ab2c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSNfda413e7-b1ae-312a-e053-6394a90ab2c630
854873zolpidem tartrate 10 MG Oral TabletSCDfda413e7-b1ae-312a-e053-6394a90ab2c630

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-323-0172789032301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-01) 2007-05-04NoNoCurrent
72789-323-107278903231010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-10) 2023-10-30NoNoCurrent
72789-323-147278903231414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-14) 2024-01-10NoNoCurrent
72789-323-157278903231515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-15) 2023-09-25NoNoCurrent
72789-323-217278903232121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-21) 2023-11-09NoNoCurrent
72789-323-307278903233030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-30) 2007-05-04NoNoCurrent
72789-323-607278903236060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-323-60) 2007-05-04NoNoCurrent