Zolpidem Tartrate

Product NDC
10370-116
11-digit product format
103700116
Labeler code
10370
Product ID
10370-116_78c500a3-0492-4838-b8d2-c9a59aa43cdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolpidem Tartrate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA078148
Marketing category
ANDA
Marketing start
2011-12-06
Marketing end
2023-07-31
Substance
ZOLPIDEM TARTRATE
Active strength
13 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
0000-00-00
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 productproduct10370-116DDiscontinued by firm2026-08-17
excluded packagepackage10370-11610370-116-10DDiscontinued by firm2026-08-17

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 · 24 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 packagepackage10370-116-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10370-116-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10370-116-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10370-116-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10370-116-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10370-116-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10370-116-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10370-116-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10370-116-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10370-116-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10370-116-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10370-116-10557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078148-001ZOLPIDEM TARTRATEZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORAL2010-12-03
A078148-002ZOLPIDEM TARTRATEZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORAL2011-04-14

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORAL2010-12-03caaa826d4ba7…
2026-08-18 06:07:402026-07A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORAL2011-04-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORAL2010-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORAL2011-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORAL2010-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORAL2011-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORAL2010-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORAL2011-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORAL2010-12-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORAL2011-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORAL2010-12-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORAL2011-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORAL2010-12-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORAL2011-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORAL2010-12-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORAL2011-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORAL2010-12-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORAL2011-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORAL2010-12-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORAL2011-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORAL2010-12-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORAL2011-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORAL2010-12-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORAL2011-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORAL2010-12-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORAL2011-04-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORAL2010-12-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORAL2011-04-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORAL2010-12-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORAL2011-04-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2011-04-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2011-04-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2011-04-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2011-04-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078148-001ZOLPIDEM TARTRATE12.5MGTABLET, EXTENDED RELEASE / ORALAB2010-12-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078148-002ZOLPIDEM TARTRATE6.25MGTABLET, EXTENDED RELEASE / ORALAB2011-04-14bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078148-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078148-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078148-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078148-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078148-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078148-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078148-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078148-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078148-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078148-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078148-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078148-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078148-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078148-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078148-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078148-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078148-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078148-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078148-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078148-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078148-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078148-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078148-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078148-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078148-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078148-002AB1ea99ee380514…
2023-05-13 08:27 UTC2023-05A078148-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A078148-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078148-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A078148-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078148-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078148-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078148-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A078148-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078148-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A078148-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078148-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078148-002AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10370-116-10EA - Each10370-11637ba7fd9-7b76-49df-87da-1313a8e8af0912012-07-24
10370-116-50EA - Each10370-11679dfd161-1822-4217-b5b5-814cf4c0b2ae12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLPIDEM TARTRATEACTIVE INGREDIENTWY6W63843KZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
ZOLPIDEMACTIVE MOIETY7K383OQI23ZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
SUCROSEINACTIVE INGREDIENTC151H8M554ZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
TALCINACTIVE INGREDIENT7SEV7J4R1UZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17
TRIACETININACTIVE INGREDIENTXHX3C3X673ZOLPIDEM TARTRATE EXTENDED-RELEASE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10370-116-1010370011610100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-116-10) 2011-12-060000-00-00NoNoCurrent