FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
55700-268
11-digit product format
557000268
Labeler code
55700
Product ID
55700-268_1b4cdbbb-d769-468a-be34-cd45849dd4bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products LLC
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
Marketing end
2026-07-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZOLPIDEM TARTRATE

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
55700-268-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET306
55700-268-60ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-268-30EA - Each55700-268ce588f41-7360-43af-a6aa-bfa6f7e1fabf12017-03-06
55700-268-60EA - Each55700-26895316304-8998-4c9b-8237-4e26e67d70ac12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-268ZOLPIDEM TARTRATE TABLET [QUALITY CARE PRODUCTS LLC]6Current NDC, Legacy NDC, 2 package rows20241219_c154b9c7-4cce-4ae0-8cff-d3de1273062e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSNc154b9c7-4cce-4ae0-8cff-d3de1273062e6
854876zolpidem tartrate 5 MG Oral TabletSCDc154b9c7-4cce-4ae0-8cff-d3de1273062e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-268-305570002683030 TABLET in 1 BOTTLE (55700-268-30) 30 tablet2015-07-312026-07-31NoNoCurrent
55700-268-605570002686060 TABLET in 1 BOTTLE (55700-268-60) 60 tablet2015-07-312026-07-31NoNoCurrent