Zolpidem Tartrate

Product NDC
80425-0060
11-digit product format
804250060
Labeler code
80425
Product ID
80425-0060_2a98ebb7-ca47-d2dd-e063-6294a90ac15c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
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

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
80425-0060-1Zolpidem Tartrate30 in 1 BOTTLETABLET, COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0060-1EA - Each80425-006092aa983b-642f-4ddf-8633-f9b951602f8e12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0060ZOLPIDEM TARTRATE TABLET, COATED [ADVANCED RX OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 1 package rows20250101_af87b722-cdb7-0b17-e053-2a95a90a315b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSNaf87b722-cdb7-0b17-e053-2a95a90a315b5
854873zolpidem tartrate 10 MG Oral TabletSCDaf87b722-cdb7-0b17-e053-2a95a90a315b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0060-18042500600130 TABLET, COATED in 1 BOTTLE (80425-0060-1) 2007-04-230000-00-00NoNoCurrent