FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
65862-160
11-digit product format
658620160
Labeler code
65862
Product ID
65862-160_20538e7c-367f-4574-a6db-a2aab4bce2ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078413
Marketing category
ANDA
Marketing start
2007-05-04
Substance
ZOLPIDEM TARTRATE
Active strength
10 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 TARTRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWY6W63843K
Rxcui854873, 854876

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
65862-160-01Zolpidem Tartrate100 in 1 BOTTLETABLET, FILM COATED10024
65862-160-05Zolpidem Tartrate500 in 1 BOTTLETABLET, FILM COATED50024
65862-160-10Zolpidem Tartrate10 in 1 CARTONTABLET, FILM COATED1024
65862-160-10Zolpidem Tartrate10 in 1 BLISTER PACKTABLET, FILM COATED1024
65862-160-99Zolpidem Tartrate1000 in 1 BOTTLETABLET, FILM COATED100024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-160-01EA - Each65862-16066ec1174-6cac-444e-bc96-f2a7d708a2b112012-07-24
65862-160-05EA - Each65862-16071aa6e56-82dd-4645-b545-5b275575a86d12012-07-24
65862-160-99EA - Each65862-160c5ce5bfc-71a5-4b7d-bd39-bbf6a9e180dc12023-10-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-160ZOLPIDEM TARTRATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]24Current NDC, Legacy NDC, 5 package rows20240201_ea2067bd-1622-4d98-8012-2c09405aa88d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSNfda413e7-b1ae-312a-e053-6394a90ab2c630
854873zolpidem tartrate 10 MG Oral TabletSCDfda413e7-b1ae-312a-e053-6394a90ab2c630
854873zolpidem tartrate 10 MG Oral TabletPSNea2067bd-1622-4d98-8012-2c09405aa88d24
854876zolpidem tartrate 5 MG Oral TabletPSNea2067bd-1622-4d98-8012-2c09405aa88d24
854873zolpidem tartrate 10 MG Oral TabletSCDea2067bd-1622-4d98-8012-2c09405aa88d24
854876zolpidem tartrate 5 MG Oral TabletSCDea2067bd-1622-4d98-8012-2c09405aa88d24
854873zolpidem tartrate 10 MG Oral TabletPSNef72eb73-d058-4ca3-9013-691aae8426fb13
854873zolpidem tartrate 10 MG Oral TabletSCDef72eb73-d058-4ca3-9013-691aae8426fb13
854873zolpidem tartrate 10 MG Oral TabletPSNc859c752-8a85-2017-e053-2a95a90a771f8
854873zolpidem tartrate 10 MG Oral TabletSCDc859c752-8a85-2017-e053-2a95a90a771f8
854873zolpidem tartrate 10 MG Oral TabletPSNcf3dcbde-b92a-4802-98e4-14f00abdf99e4
854873zolpidem tartrate 10 MG Oral TabletSCDcf3dcbde-b92a-4802-98e4-14f00abdf99e4
854873zolpidem tartrate 10 MG Oral TabletPSN67cc924a-26e0-431f-9160-32c9d92a46cd3
854873zolpidem tartrate 10 MG Oral TabletSCD67cc924a-26e0-431f-9160-32c9d92a46cd3
854873zolpidem tartrate 10 MG Oral TabletPSN9922ce14-b418-4235-9c59-d674a8e702101
854873zolpidem tartrate 10 MG Oral TabletPSN2b9f696a-b637-4dea-e063-6394a90aeb2e1
854873zolpidem tartrate 10 MG Oral TabletPSN7abb6898-223c-487b-856c-068ac04f7a5c1
854876zolpidem tartrate 5 MG Oral TabletPSN9922ce14-b418-4235-9c59-d674a8e702101
854876zolpidem tartrate 5 MG Oral TabletPSN7abb6898-223c-487b-856c-068ac04f7a5c1
854873zolpidem tartrate 10 MG Oral TabletSCD9922ce14-b418-4235-9c59-d674a8e702101
854873zolpidem tartrate 10 MG Oral TabletSCD7abb6898-223c-487b-856c-068ac04f7a5c1
854873zolpidem tartrate 10 MG Oral TabletSCD2b9f696a-b637-4dea-e063-6394a90aeb2e1
854876zolpidem tartrate 5 MG Oral TabletSCD9922ce14-b418-4235-9c59-d674a8e702101
854876zolpidem tartrate 5 MG Oral TabletSCD7abb6898-223c-487b-856c-068ac04f7a5c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-160-0165862016001100 TABLET, FILM COATED in 1 BOTTLE (65862-160-01) 2007-05-040000-00-00NoNoCurrent
65862-160-0565862016005500 TABLET, FILM COATED in 1 BOTTLE (65862-160-05) 2007-05-040000-00-00NoNoCurrent
65862-160-106586201601010 BLISTER PACK in 1 CARTON (65862-160-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2007-05-040000-00-00NoNoCurrent
65862-160-61658620160616000 TABLET, FILM COATED in 1 BAG (65862-160-61)04-MAY-07Current
65862-160-99658620160991000 TABLET, FILM COATED in 1 BOTTLE (65862-160-99) 2007-05-040000-00-00NoNoCurrent