FDA.reportPublic FDA data

Zolpidem

Product NDC
63629-8999
11-digit product format
636298999
Labeler code
63629
Product ID
63629-8999_4157e8f6-e039-4ec4-b619-e787a32dc757
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077214
Marketing category
ANDA
Marketing start
2020-09-24
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
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
63629-8999-1Zolpidem30 in 1 BOTTLETABLET30103
63629-8999-2Zolpidem60 in 1 BOTTLETABLET60103
63629-8999-3Zolpidem90 in 1 BOTTLETABLET90103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8999-1EA - Each63629-8999152ed5e3-ff42-4f98-a78b-faaf31e3bc9012022-03-09
63629-8999-2EA - Each63629-89999a2e6161-4dc5-49c1-9478-972030b79a4512022-03-09
63629-8999-3EA - Each63629-899956cc42d1-00bb-4d0b-ac64-645acd4aaa2912022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8999ZOLPIDEM (ZOLPIDEM TARTRATE) TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 3 package rows20240509_3aa7e88b-7929-45ac-9e81-03f4abf28e94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN3aa7e88b-7929-45ac-9e81-03f4abf28e94103
854873zolpidem tartrate 10 MG Oral TabletSCD3aa7e88b-7929-45ac-9e81-03f4abf28e94103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8999-16362989990130 TABLET in 1 BOTTLE (63629-8999-1) 30 tablet2024-04-040000-00-00NoNoCurrent
63629-8999-26362989990260 TABLET in 1 BOTTLE (63629-8999-2) 60 tablet2024-04-040000-00-00NoNoCurrent
63629-8999-36362989990390 TABLET in 1 BOTTLE (63629-8999-3) 90 tablet2024-04-040000-00-00NoNoCurrent