FDA.reportPublic FDA data

ZOLPIDEM TARTRATE

Product NDC
13668-008
11-digit product format
136680008
Labeler code
13668
Product ID
13668-008_783b6c2c-bec3-44db-b758-d762377a34ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA077903
Marketing category
ANDA
Marketing start
2007-09-05
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 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
13668-008-01ZOLPIDEM TARTRATE100 in 1 BOTTLETABLET10024
13668-008-05ZOLPIDEM TARTRATE500 in 1 BOTTLETABLET50024
13668-008-10ZOLPIDEM TARTRATE1000 in 1 BOTTLETABLET100024
13668-008-15ZOLPIDEM TARTRATE1500 in 1 BOTTLETABLET150024
13668-008-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET3024
13668-008-90ZOLPIDEM TARTRATE90 in 1 BOTTLETABLET9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-008-01EA - Each13668-008408b28ce-9f95-4a89-a933-5cc463c8d51012012-07-24
13668-008-05EA - Each13668-008b5029160-e8d6-46a2-a09c-1a9190a6ef6312012-07-24
13668-008-10EA - Each13668-0084d7f6028-463c-4ba1-af18-5d1e6341ec2612012-07-24
13668-008-15EA - Each13668-00880733af8-8a6d-4b0c-8038-7c85a5ecee7f12012-07-24
13668-008-30EA - Each13668-0089adf4d70-b1a1-4714-a7f1-65851507406312012-07-24
13668-008-74EA - Each13668-0084099426f-51bf-4a51-b96a-7703fb17132e12012-07-24
13668-008-90EA - Each13668-0087628ad12-220f-451b-95df-1dfa8c3b0b3612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]10
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]10
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [MAJOR PHARMACEUTICALS]9
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]9
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [MAJOR PHARMACEUTICALS]9
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [MAJOR PHARMACEUTICALS]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]9
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [MEDSOURCE PHARMACEUTICALS]3
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [MEDSOURCE PHARMACEUTICALS]3
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [MEDSOURCE PHARMACEUTICALS]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [TYA PHARMACEUTICALS]2
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [TYA PHARMACEUTICALS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET [STAT RX USA LLC]2
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]1
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]1
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [PROFICIENT RX LP]1
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [PROFICIENT RX LP]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [H.J. HARKINS COMPANY, INC.]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [REBEL DISTRIBUTORS CORP.]1
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET [AIDAREX PHARMACEUTICALS LLC]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
13668-008ZOLPIDEM TARTRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]24Current NDC, Legacy NDC, 6 package rows20240808_1584bad1-7bf4-4805-bdd9-7eb0fac92721.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN1584bad1-7bf4-4805-bdd9-7eb0fac9272124
854876zolpidem tartrate 5 MG Oral TabletPSN1584bad1-7bf4-4805-bdd9-7eb0fac9272124
854873zolpidem tartrate 10 MG Oral TabletSCD1584bad1-7bf4-4805-bdd9-7eb0fac9272124
854876zolpidem tartrate 5 MG Oral TabletSCD1584bad1-7bf4-4805-bdd9-7eb0fac9272124
854873zolpidem tartrate 10 MG Oral TabletPSNd34336b1-7041-4078-beda-94bc9d9f771e19
854876zolpidem tartrate 5 MG Oral TabletPSNd34336b1-7041-4078-beda-94bc9d9f771e19
854873zolpidem tartrate 10 MG Oral TabletSCDd34336b1-7041-4078-beda-94bc9d9f771e19
854876zolpidem tartrate 5 MG Oral TabletSCDd34336b1-7041-4078-beda-94bc9d9f771e19
854873zolpidem tartrate 10 MG Oral TabletPSN3bbc3c35-2811-4a67-9dcc-5eed38ef8b5215
854873zolpidem tartrate 10 MG Oral TabletSCD3bbc3c35-2811-4a67-9dcc-5eed38ef8b5215
854873zolpidem tartrate 10 MG Oral TabletPSNdb735db9-1c82-4d32-bf91-97b05a75e87612
854873zolpidem tartrate 10 MG Oral TabletPSNa9ac3d4e-f502-41e3-95c0-0d334584566d12
854876zolpidem tartrate 5 MG Oral TabletPSNa9ac3d4e-f502-41e3-95c0-0d334584566d12
854873zolpidem tartrate 10 MG Oral TabletSCDdb735db9-1c82-4d32-bf91-97b05a75e87612
854873zolpidem tartrate 10 MG Oral TabletSCDa9ac3d4e-f502-41e3-95c0-0d334584566d12
854876zolpidem tartrate 5 MG Oral TabletSCDa9ac3d4e-f502-41e3-95c0-0d334584566d12
854873zolpidem tartrate 10 MG Oral TabletPSN1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee8
854876zolpidem tartrate 5 MG Oral TabletPSN1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee8
854873zolpidem tartrate 10 MG Oral TabletSCD1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee8
854876zolpidem tartrate 5 MG Oral TabletSCD1211fbc0-7b2a-4bd0-8be4-9fdcc0553aee8
854873zolpidem tartrate 10 MG Oral TabletPSN507225e2-80ba-18c4-e054-00144ff88e887
854873zolpidem tartrate 10 MG Oral TabletPSN96d08f88-c841-46d6-958d-7f45656e672c7
854873zolpidem tartrate 10 MG Oral TabletPSNaf87ae17-a3c5-a3a5-e053-2a95a90aa4b07
854876zolpidem tartrate 5 MG Oral TabletPSN96d08f88-c841-46d6-958d-7f45656e672c7
854873zolpidem tartrate 10 MG Oral TabletSCDaf87ae17-a3c5-a3a5-e053-2a95a90aa4b07
854873zolpidem tartrate 10 MG Oral TabletSCD96d08f88-c841-46d6-958d-7f45656e672c7
854873zolpidem tartrate 10 MG Oral TabletSCD507225e2-80ba-18c4-e054-00144ff88e887
854876zolpidem tartrate 5 MG Oral TabletSCD96d08f88-c841-46d6-958d-7f45656e672c7
854873zolpidem tartrate 10 MG Oral TabletPSN4be6ce23-e7b1-510e-e054-00144ff8d46c6
854873zolpidem tartrate 10 MG Oral TabletSCD4be6ce23-e7b1-510e-e054-00144ff8d46c6
854873zolpidem tartrate 10 MG Oral TabletPSNeaca34da-2b12-4dd4-91b5-a8446c7bd41e5
854873zolpidem tartrate 10 MG Oral TabletPSN95b0ba48-4e71-25f7-e053-2a95a90aea825
854873zolpidem tartrate 10 MG Oral TabletSCDeaca34da-2b12-4dd4-91b5-a8446c7bd41e5
854873zolpidem tartrate 10 MG Oral TabletSCD95b0ba48-4e71-25f7-e053-2a95a90aea825
854873zolpidem tartrate 10 MG Oral TabletPSN25f1176d-5195-1a99-e054-00144ff8d46c4
854873zolpidem tartrate 10 MG Oral TabletSCD25f1176d-5195-1a99-e054-00144ff8d46c4
854873zolpidem tartrate 10 MG Oral TabletPSN92c6cc45-c28b-729b-e053-2a95a90a7ccb3
854873zolpidem tartrate 10 MG Oral TabletPSN98e5208b-5109-58c6-e053-2995a90a994a3
854873zolpidem tartrate 10 MG Oral TabletPSN1b66047b-4782-4808-e054-00144ff8d46c3
854873zolpidem tartrate 10 MG Oral TabletPSNc0543e05-3220-4a8a-abd9-6a73c42848c23
854876zolpidem tartrate 5 MG Oral TabletPSNc0543e05-3220-4a8a-abd9-6a73c42848c23
854873zolpidem tartrate 10 MG Oral TabletSCD92c6cc45-c28b-729b-e053-2a95a90a7ccb3
854873zolpidem tartrate 10 MG Oral TabletSCDc0543e05-3220-4a8a-abd9-6a73c42848c23
854873zolpidem tartrate 10 MG Oral TabletSCD98e5208b-5109-58c6-e053-2995a90a994a3
854873zolpidem tartrate 10 MG Oral TabletSCD1b66047b-4782-4808-e054-00144ff8d46c3
854876zolpidem tartrate 5 MG Oral TabletSCDc0543e05-3220-4a8a-abd9-6a73c42848c23
854873zolpidem tartrate 10 MG Oral TabletPSNb87ea23e-2d54-4d10-8f10-72d4c62f32452
854873zolpidem tartrate 10 MG Oral TabletPSNe5e2d31b-ce26-78b0-e053-2a95a90ac4912
854873zolpidem tartrate 10 MG Oral TabletPSNfc76ab4c-3607-39c3-e053-6394a90a68772
854873zolpidem tartrate 10 MG Oral TabletPSN11934d96-36f4-4c32-b14a-a665c7400f3b2
854873zolpidem tartrate 10 MG Oral TabletPSN7da75d2b-905c-4fdf-bc53-1358c64777552
854873zolpidem tartrate 10 MG Oral TabletPSN26e20f53-c042-eac0-e063-6394a90acfca2
854876zolpidem tartrate 5 MG Oral TabletPSNb87ea23e-2d54-4d10-8f10-72d4c62f32452
854876zolpidem tartrate 5 MG Oral TabletPSNe5e2d31b-ce26-78b0-e053-2a95a90ac4912
854873zolpidem tartrate 10 MG Oral TabletSCDfc76ab4c-3607-39c3-e053-6394a90a68772
854873zolpidem tartrate 10 MG Oral TabletSCDb87ea23e-2d54-4d10-8f10-72d4c62f32452
854873zolpidem tartrate 10 MG Oral TabletSCDe5e2d31b-ce26-78b0-e053-2a95a90ac4912
854873zolpidem tartrate 10 MG Oral TabletSCD11934d96-36f4-4c32-b14a-a665c7400f3b2
854873zolpidem tartrate 10 MG Oral TabletSCD7da75d2b-905c-4fdf-bc53-1358c64777552
854873zolpidem tartrate 10 MG Oral TabletSCD26e20f53-c042-eac0-e063-6394a90acfca2
854876zolpidem tartrate 5 MG Oral TabletSCDb87ea23e-2d54-4d10-8f10-72d4c62f32452
854876zolpidem tartrate 5 MG Oral TabletSCDe5e2d31b-ce26-78b0-e053-2a95a90ac4912
854873zolpidem tartrate 10 MG Oral TabletPSN7efb19d9-32bb-4737-ac7f-2ec21eca255c1
854873zolpidem tartrate 10 MG Oral TabletPSNe68a1b3b-b3d1-495e-be46-466113e7dbd61
854873zolpidem tartrate 10 MG Oral TabletPSN9245ff4b-a11f-4afd-8fa0-842fcfee43061
854873zolpidem tartrate 10 MG Oral TabletPSN06a454bc-50d0-45de-87db-f3e3502e3bb01
854876zolpidem tartrate 5 MG Oral TabletPSN7efb19d9-32bb-4737-ac7f-2ec21eca255c1
854876zolpidem tartrate 5 MG Oral TabletPSN06a454bc-50d0-45de-87db-f3e3502e3bb01
854873zolpidem tartrate 10 MG Oral TabletSCD7efb19d9-32bb-4737-ac7f-2ec21eca255c1
854873zolpidem tartrate 10 MG Oral TabletSCD9245ff4b-a11f-4afd-8fa0-842fcfee43061
854873zolpidem tartrate 10 MG Oral TabletSCDe68a1b3b-b3d1-495e-be46-466113e7dbd61
854873zolpidem tartrate 10 MG Oral TabletSCD06a454bc-50d0-45de-87db-f3e3502e3bb01
854876zolpidem tartrate 5 MG Oral TabletSCD7efb19d9-32bb-4737-ac7f-2ec21eca255c1
854876zolpidem tartrate 5 MG Oral TabletSCD06a454bc-50d0-45de-87db-f3e3502e3bb01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-008-0113668000801100 TABLET in 1 BOTTLE (13668-008-01) 100 tablet2007-09-050000-00-00NoNoCurrent
13668-008-0513668000805500 TABLET in 1 BOTTLE (13668-008-05) 500 tablet2007-09-050000-00-00NoNoCurrent
13668-008-10136680008101000 TABLET in 1 BOTTLE (13668-008-10) 1000 tablet2007-09-050000-00-00NoNoCurrent
13668-008-15136680008151500 TABLET in 1 BOTTLE (13668-008-15) 1500 tablet2007-09-050000-00-00NoNoCurrent
13668-008-301366800083030 TABLET in 1 BOTTLE (13668-008-30) 30 tablet2007-09-050000-00-00NoNoCurrent
13668-008-7413668000874100 TABLET in 1 CARTON (13668-008-74) 100 tablet2007-09-050000-00-00NoNoCurrent
13668-008-901366800089090 TABLET in 1 BOTTLE (13668-008-90) 90 tablet2007-09-050000-00-00NoNoCurrent