ZOLPIDEM TARTRATE

Product NDC
61919-527
11-digit product format
619190527
Labeler code
61919
Product ID
61919-527_ec8f5298-4530-44fe-9059-89b97cba1712
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZOLPIDEM TARTRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078616
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
ZOLPIDEM TARTRATE
Active strength
10 mg/1
Pharmacologic classes
gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-527IInactivated by FDA2026-08-07
excluded packagepackage61919-52761919-527-10IInactivated by FDA2026-08-07
excluded packagepackage61919-52761919-527-30IInactivated by FDA2026-08-07
excluded packagepackage61919-52761919-527-60IInactivated by FDA2026-08-07

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 2 · 88 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 packagepackage61919-527-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-527-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-527-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-527-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-527-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-527-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-527-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-527-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-527-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-527-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-527-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-527-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-527-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-527-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-527-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-527-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-527-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-527-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-527-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-527-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-527-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-527-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-527-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-527-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-527-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-527-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-527-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-527-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-527-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-527-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-527-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-527-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-527-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-527-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-527-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-527-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-527-108af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-527-608af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-527-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-527-10834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-527-60834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-527-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-527-101332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-527-601332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-527-301332a3947898…d4bfe170f9cd…

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
A078616-001ZOLPIDEM TARTRATEZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-21
A078616-002ZOLPIDEM TARTRATEZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-21

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 UTC2026-02A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2008-11-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2008-11-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078616-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2008-11-21782e0a99824c…
2021-12-28 21:50 UTC2021-12A078616-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2008-11-21782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A078616-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078616-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A078616-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078616-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078616-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078616-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078616-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078616-002AB1ea99ee380514…

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
61919-527-102020-01-31C16284748780-19d75b9cf-fbae-f424-e053-dadaa90a57ceZOLPIDEM TARTRATE
61919-527-302020-01-31C16284748780-19d75b9cf-fbae-f424-e053-dadaa90a57ceZOLPIDEM TARTRATE
61919-527-602020-01-31C16284748780-19d75b9cf-fbae-f424-e053-dadaa90a57ceZOLPIDEM TARTRATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-527-10ZOLPIDEM TARTRATE10 in 1 BOTTLETABLET, FILM COATED104
61919-527-30ZOLPIDEM TARTRATE30 in 1 BOTTLETABLET, FILM COATED304
61919-527-60ZOLPIDEM TARTRATE60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-527-30EA - Each61919-527459349dd-7f17-4aad-9303-89f2e323c0d912015-03-03
61919-527-60EA - Each61919-527a78ffa0a-a854-4a04-872d-3baafc353b5112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4
TRIACETININACTIVE INGREDIENTXHX3C3X673ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-527ZOLPIDEM TARTRATE TABLET, FILM COATED [DIRECT RX]4Legacy NDC, 3 package rows20151109_5baa7cf2-b6a6-4611-b4ad-7fe142220e2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854873zolpidem tartrate 10 MG Oral TabletPSN5baa7cf2-b6a6-4611-b4ad-7fe142220e2b4
854873zolpidem tartrate 10 MG Oral TabletSCD5baa7cf2-b6a6-4611-b4ad-7fe142220e2b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-527-106191905271010 in 1 BOTTLEHistorical
61919-527-306191905273030 in 1 BOTTLEHistorical
61919-527-606191905276060 in 1 BOTTLEHistorical