Zolpidem Tartrate

Product NDC
50090-5096
11-digit product format
500905096
Labeler code
50090
Product ID
50090-5096_837fd2cc-013b-4e35-972f-d399abcebb1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078413
Marketing category
ANDA
Marketing start
2007-05-04
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
5 mg/1
Pharmacologic classes
gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-5096DDiscontinued by firm2026-08-03
excluded packagepackage50090-509650090-5096-0DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-5096-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-5096-0f5e01cc5f278…a2eaf40c39c3…

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…

FDA-Initiated Inactive NDC Indexing#

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5096-05009050960090 TABLET, FILM COATED in 1 BOTTLE (50090-5096-0) 2020-07-080000-00-00NoNoCurrent