Zolpidem Tartrate

Product NDC
76420-417
Requested package NDC
76420-417-30
11-digit product format
764200417
Labeler code
76420
Product ID
76420-417_3aa8cb56-eaef-625f-e063-6394a90a52ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
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 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078413-001ZOLPIDEM TARTRATEZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-04
A078413-002ZOLPIDEM TARTRATEZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A078413-001AB
A078413-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078413-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-05-04782e0a99824c…
2021-12-28 21:50 UTC2021-12A078413-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-05-04782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078413-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078413-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078413-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078413-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078413-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078413-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078413-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078413-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078413-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078413-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078413-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078413-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078413-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078413-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078413-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078413-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078413-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078413-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078413-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078413-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078413-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078413-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078413-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078413-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078413-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078413-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078413-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078413-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078413-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078413-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078413-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078413-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078413-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078413-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078413-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078413-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078413-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078413-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078413-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078413-002AB1782e0a99824c…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WY6W63843KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
854873Internal RxNorm lookup
854876Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9922ce14-b418-4235-9c59-d674a8e70210Available on FDA.report

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
76420-417-00Zolpidem Tartrate1000 in 1 BOTTLETABLET, FILM COATED10001
76420-417-01Zolpidem Tartrate100 in 1 BOTTLETABLET, FILM COATED1001
76420-417-05Zolpidem Tartrate500 in 1 BOTTLETABLET, FILM COATED5001
76420-417-30Zolpidem Tartrate30 in 1 BOTTLETABLET, FILM COATED301
76420-417-60Zolpidem Tartrate60 in 1 BOTTLETABLET, FILM COATED601
76420-417-90Zolpidem Tartrate90 in 1 BOTTLETABLET, FILM COATED901

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zolpidem TartrateZOLPIDEM TARTRATEREMEDYREPACK INC.cf3dcbde-b92a-4802-98e4-14f00abdf99e2026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutions2556c804-7a5e-4dbd-aeef-a3ba3a247c392026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutionsf67ef513-1b2c-42fe-bf33-4c7e9db191a32026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutions91511d2f-7066-49a0-90ea-2940d955c85e2025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutionsef72eb73-d058-4ca3-9013-691aae8426fb2025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATEAsclemed USA, Inc.9922ce14-b418-4235-9c59-d674a8e702102025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
ndc (package): 76420-417-30
ndc (product): 76420-417
ndc11 (package): 76420041730
Zolpidem TartrateZOLPIDEM TARTRATEPD-Rx Pharmaceuticals, Inc.38c838a4-9943-445a-8e80-e823d56eeaa52025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATEPD-Rx Pharmaceuticals, Inc.fda413e7-b1ae-312a-e053-6394a90ab2c62025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATENuCare Pharmaceuticals, Inc.2b9f696a-b637-4dea-e063-6394a90aeb2e2025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCaf87df4e-2c97-e23e-e053-2a95a90ab3542024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx of Tennessee, LLCb2db3979-daa6-6e83-e053-2a95a90a3a2f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATEAdvanced Rx Pharmacy of Tennessee, LLCc859c752-8a85-2017-e053-2a95a90a771f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutions3ba3c29f-3835-4f4f-a39f-56fb42686f5b2024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATEAmerican Health Packagingeb850154-4b4b-4d9a-8476-aea1a93fe8d72024-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATEAurobindo Pharma Limitedea2067bd-1622-4d98-8012-2c09405aa88d2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATENorthStar Rx LLC51c9a29c-a285-40d0-bf3a-7e8c944ee39c2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATEA-S Medication Solutions67cc924a-26e0-431f-9160-32c9d92a46cd2023-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLCacfcfe91-83a0-44ab-95c0-dd98b73ac69a2019-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC7be7f243-e6f8-406f-aed7-be7cedd5630a2018-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413
Zolpidem TartrateZOLPIDEM TARTRATEAphena Pharma Solutions - Tennessee, LLC7abb6898-223c-487b-856c-068ac04f7a5c2018-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078413
application number: ANDA078413

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN9922ce14-b418-4235-9c59-d674a8e702101
854876zolpidem tartrate 5 MG Oral TabletPSN9922ce14-b418-4235-9c59-d674a8e702101
854873zolpidem tartrate 10 MG Oral TabletSCD9922ce14-b418-4235-9c59-d674a8e702101
854876zolpidem tartrate 5 MG Oral TabletSCD9922ce14-b418-4235-9c59-d674a8e702101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-417-307642004173030 TABLET, FILM COATED in 1 BOTTLE (76420-417-30) 2025-07-24NoNoCurrent