FDA.reportPublic FDA data

Zolpidem

Product NDC
63629-8998
11-digit product format
636298998
Labeler code
63629
Product ID
63629-8998_c217161f-de96-46ab-906c-c628685a6428
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
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
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 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
63629-8998-1Zolpidem30 in 1 BOTTLETABLET30104
63629-8998-2Zolpidem60 in 1 BOTTLETABLET60104
63629-8998-3Zolpidem90 in 1 BOTTLETABLET90104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8998-1EA - Each63629-8998dbf75a5a-08f7-4a8e-80bd-b3a4b6f78ca712022-03-09
63629-8998-2EA - Each63629-89982c8c491a-1d41-4c03-a665-4b9ba5edd2ce12022-03-09
63629-8998-3EA - Each63629-899898629d04-81b3-409a-9c08-5de275c5acdc12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8998ZOLPIDEM (ZOLPIDEM TARTRATE) TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 3 package rows20240905_8cef5718-c562-43c3-8abe-a2fc5235ad2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSN8cef5718-c562-43c3-8abe-a2fc5235ad2a104
854876zolpidem tartrate 5 MG Oral TabletSCD8cef5718-c562-43c3-8abe-a2fc5235ad2a104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8998-16362989980130 TABLET in 1 BOTTLE (63629-8998-1) 30 tablet2024-04-040000-00-00NoNoCurrent
63629-8998-26362989980260 TABLET in 1 BOTTLE (63629-8998-2) 60 tablet2024-04-040000-00-00NoNoCurrent
63629-8998-36362989980390 TABLET in 1 BOTTLE (63629-8998-3) 90 tablet2024-04-040000-00-00NoNoCurrent