FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
63187-558
11-digit product format
631870558
Labeler code
63187
Product ID
63187-558_abcdf937-6cde-4adf-97fe-599ac82e20f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
Substance
ZOLPIDEM TARTRATE
Active strength
5 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [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 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
63187-558-05ZOLPIDEM TARTRATE5 in 1 BOTTLETABLET55
63187-558-15ZOLPIDEM TARTRATE15 in 1 BOTTLETABLET155
63187-558-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET305
63187-558-60ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET605
63187-558-90ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-558-05EA - Each63187-5581c010fe5-5fbf-4de5-bc25-508d58bd91cb12019-04-11
63187-558-15EA - Each63187-558f81a066e-4b75-41cd-a280-f0dd06fafe1412016-04-04
63187-558-30EA - Each63187-55893a13153-8bd4-4bcc-a3c9-49b62378004312017-11-06
63187-558-60EA - Each63187-5588cb3196e-2bbb-4416-8925-23c50e29ba7e12016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [PROFICIENT RX LP]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-558ZOLPIDEM TARTRATE TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 5 package rows20220419_e1f43bde-efba-42be-adef-94e1ef6664fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSNe1f43bde-efba-42be-adef-94e1ef6664fd5
854876zolpidem tartrate 5 MG Oral TabletSCDe1f43bde-efba-42be-adef-94e1ef6664fd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-558-05631870558055 TABLET in 1 BOTTLE (63187-558-05) 5 tablet2019-02-010000-00-00NoNoCurrent
63187-558-156318705581515 TABLET in 1 BOTTLE (63187-558-15) 15 tablet2018-12-010000-00-00NoNoCurrent
63187-558-306318705583030 TABLET in 1 BOTTLE (63187-558-30) 30 tablet2018-12-010000-00-00NoNoCurrent
63187-558-606318705586060 TABLET in 1 BOTTLE (63187-558-60) 60 tablet2018-12-010000-00-00NoNoCurrent
63187-558-906318705589090 TABLET in 1 BOTTLE (63187-558-90) 90 tablet2018-12-010000-00-00NoNoCurrent