FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
63629-3549
11-digit product format
636293549
Labeler code
63629
Product ID
63629-3549_0e3b2506-9d0e-40cf-b8b1-72d0ef4a0c37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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 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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-3549-02020-10-14C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-12020-10-14C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-22020-10-14C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-32020-10-14C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-42020-10-14C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-52020-10-14C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-62020-10-14C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-72020-10-14C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-82020-10-14C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-92020-10-14C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-02020-01-31C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-12020-01-31C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-22020-01-31C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-32020-01-31C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-42020-01-31C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-52020-01-31C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-62020-01-31C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-72020-01-31C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-82020-01-31C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.
63629-3549-92020-01-31C16284748780-19d75b9d0-0b71-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOLPIDEM TARTRATE TABLETS safely and effectively. See full prescribing information for ZOLPIDEM TARTRATE TABLETS. ZOLPIDEM TARTRATE tablets, for oral use C IV Initial U.S. Approval: 1992.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-3549-0ZOLPIDEM TARTRATE25 in 1 BOTTLETABLET2516
63629-3549-1ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET3016
63629-3549-2ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET6016
63629-3549-3ZOLPIDEM TARTRATE10 in 1 BOTTLETABLET1016
63629-3549-4ZOLPIDEM TARTRATE100 in 1 BOTTLETABLET10016
63629-3549-5ZOLPIDEM TARTRATE20 in 1 BOTTLETABLET2016
63629-3549-6ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET9016
63629-3549-7ZOLPIDEM TARTRATE56 in 1 BOTTLETABLET5616
63629-3549-8ZOLPIDEM TARTRATE28 in 1 BOTTLETABLET2816
63629-3549-9ZOLPIDEM TARTRATE120 in 1 BOTTLETABLET12016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3549-1EA - Each63629-3549198377f3-2ed0-49ce-a245-843222e373e712012-07-24
63629-3549-2EA - Each63629-3549fe43994d-7a85-496d-b542-ae52f65ff48a12012-07-24
63629-3549-3EA - Each63629-3549cb92e622-ba6a-47a7-9899-f21ec77b581a12012-07-24
63629-3549-4EA - Each63629-35491f9e7410-f47e-4755-b2c4-23212fe43eb312012-07-24
63629-3549-5EA - Each63629-354978fe2869-14d9-4231-904f-de06852dc4ed12012-07-24
63629-3549-6EA - Each63629-35495f5368b7-a20f-46b1-a55e-159fbabed61712012-07-24
63629-3549-7EA - Each63629-35496bc02eef-7491-483f-b317-ad7e1cc31be912015-10-02
63629-3549-8EA - Each63629-3549f15bdd58-5b61-4adc-b813-15adb8f3e54912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3549ZOLPIDEM TARTRATE TABLET [BRYANT RANCH PREPACK]16Current NDC, Legacy NDC, 10 package rows20240901_413b6f65-101e-e2cf-0802-711d080b851b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854876zolpidem tartrate 5 MG Oral TabletPSN413b6f65-101e-e2cf-0802-711d080b851b16
854876zolpidem tartrate 5 MG Oral TabletSCD413b6f65-101e-e2cf-0802-711d080b851b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3549-06362935490025 TABLET in 1 BOTTLE (63629-3549-0) 25 tablet2013-04-260000-00-00NoNoCurrent
63629-3549-16362935490130 TABLET in 1 BOTTLE (63629-3549-1) 30 tablet2024-08-080000-00-00NoNoCurrent
63629-3549-26362935490260 TABLET in 1 BOTTLE (63629-3549-2) 60 tablet2008-08-120000-00-00NoNoCurrent
63629-3549-36362935490310 TABLET in 1 BOTTLE (63629-3549-3) 10 tablet2009-01-070000-00-00NoNoCurrent
63629-3549-463629354904100 TABLET in 1 BOTTLE (63629-3549-4) 100 tablet2009-02-060000-00-00NoNoCurrent
63629-3549-56362935490520 TABLET in 1 BOTTLE (63629-3549-5) 20 tablet2009-10-010000-00-00NoNoCurrent
63629-3549-66362935490690 TABLET in 1 BOTTLE (63629-3549-6) 90 tablet2010-03-290000-00-00NoNoCurrent
63629-3549-76362935490756 TABLET in 1 BOTTLE (63629-3549-7) 56 tablet2010-03-020000-00-00NoNoCurrent
63629-3549-86362935490828 TABLET in 1 BOTTLE (63629-3549-8) 28 tablet2010-07-200000-00-00NoNoCurrent
63629-3549-963629354909120 TABLET in 1 BOTTLE (63629-3549-9) 120 tablet2014-10-030000-00-00NoNoCurrent