FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
55700-357
11-digit product format
557000357
Labeler code
55700
Product ID
55700-357_441aafa7-9b54-4c40-8339-afb197dab6e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
Marketing end
2027-10-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZOLPIDEM TARTRATE

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
55700-357-15ZOLPIDEM TARTRATE15 in 1 BOTTLETABLET1512
55700-357-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET3012
55700-357-60ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-357-15EA - Each55700-3579424d913-e812-4019-9ba6-6194087971e912016-05-16
55700-357-30EA - Each55700-35795a558fd-f71e-486b-8e63-9bb4fcaa49e612016-05-16
55700-357-60EA - Each55700-3578a507446-ce84-4668-b430-f979d6272a5412016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-357ZOLPIDEM TARTRATE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]12Current NDC, Legacy NDC, 3 package rows20241219_db735db9-1c82-4d32-bf91-97b05a75e876.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSNdb735db9-1c82-4d32-bf91-97b05a75e87612
854873zolpidem tartrate 10 MG Oral TabletSCDdb735db9-1c82-4d32-bf91-97b05a75e87612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-357-155570003571515 in 1 BOTTLEHistorical
55700-357-305570003573030 TABLET in 1 BOTTLE (55700-357-30) 30 tablet2016-01-132027-10-31NoNoCurrent
55700-357-605570003576060 TABLET in 1 BOTTLE (55700-357-60) 60 tablet2016-01-130000-00-00NoNoCurrent