FDA.reportPublic FDA data

Zolpidem Tartrate

Product NDC
67544-996
11-digit product format
675440996
Labeler code
67544
Product ID
67544-996_50878745-f6d3-4a5c-ba86-83814855db5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolpidem tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076578
Marketing category
ANDA
Marketing start
2007-04-23
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]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 15 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67544-996DDiscontinued by firm2026-08-03
excluded packagepackage67544-99667544-996-07DDiscontinued by firm2026-08-03
excluded packagepackage67544-99667544-996-10DDiscontinued by firm2026-08-03
excluded packagepackage67544-99667544-996-14DDiscontinued by firm2026-08-03
excluded packagepackage67544-99667544-996-15DDiscontinued by firm2026-08-03
excluded packagepackage67544-99667544-996-20DDiscontinued by firm2026-08-03
excluded packagepackage67544-99667544-996-21DDiscontinued by firm2026-08-03
excluded packagepackage67544-99667544-996-25DDiscontinued by firm2026-08-03
excluded packagepackage67544-99667544-996-28DDiscontinued by firm2026-08-03
excluded packagepackage67544-99667544-996-30DDiscontinued by firm2026-08-03
excluded packagepackage67544-99667544-996-45DDiscontinued by firm2026-08-03
excluded packagepackage67544-99667544-996-53DDiscontinued by firm2026-08-03
excluded packagepackage67544-99667544-996-59DDiscontinued by firm2026-08-03
excluded packagepackage67544-99667544-996-60DDiscontinued by firm2026-08-03
excluded packagepackage67544-99667544-996-62DDiscontinued 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 3 · 180 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 packagepackage67544-996-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-996-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-996-62d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-996-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-996-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-996-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-996-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-996-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-996-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-996-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-996-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-996-53d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-996-59d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-996-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-996-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-996-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-996-62f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-996-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-996-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-996-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-996-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-996-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-996-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-996-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-996-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-996-53f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-996-59f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-996-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-996-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-996-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-996-622ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-996-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-996-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-996-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-996-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-996-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-996-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-996-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-996-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-996-532ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-996-592ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-996-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-996-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-996-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-996-62a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-996-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-996-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-996-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-996-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-996-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-996-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-996-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-996-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-996-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-996-59a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-996-25a1b67e2a42f9…c4cf2c586c0d…

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
A076578-001ZOLPIDEM TARTRATEZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-23
A076578-002ZOLPIDEM TARTRATEZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-23

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 UTC2026-02A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORALAB2007-04-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORALAB2007-04-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076578-001ZOLPIDEM TARTRATE5MGTABLET / ORAL2007-04-23782e0a99824c…
2021-12-28 21:50 UTC2021-12A076578-002ZOLPIDEM TARTRATE10MGTABLET / ORAL2007-04-23782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076578-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076578-002AB174a2ff9319b5…
2019-09-15 20:21 UTC2019-09A076578-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076578-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076578-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076578-002AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-996-10EA - Each67544-9969c94eecc-b24f-41ff-90ef-ba724085b29b12017-11-06
67544-996-14EA - Each67544-996a662b4e4-d815-419e-8447-180f4896bae312017-11-06
67544-996-15EA - Each67544-996dafc7fcb-0d4e-40e2-a63c-00b02f7ce85112017-11-06
67544-996-20EA - Each67544-996e527b4dd-d829-4f2e-a4b4-93268c8c07fb12017-11-06
67544-996-21EA - Each67544-996f46c85b9-add6-4994-8c68-296e9429de3612017-11-06
67544-996-28EA - Each67544-996f77ddd68-5676-475e-95c9-3fd74eccf1de12017-11-06
67544-996-30EA - Each67544-996f5cdfdfe-6538-4db6-b772-01129d36679412017-11-06
67544-996-45EA - Each67544-9967856dcc8-6088-4ea2-8395-4d1032cb74c212017-11-06
67544-996-53EA - Each67544-996693ea78a-5bb2-4d48-9b7e-5c49fd841e2312017-11-06
67544-996-59EA - Each67544-99622ec9039-0d48-40f1-ac43-ea99a70fd0d912017-11-06
67544-996-60EA - Each67544-99659a3e4e5-bbb9-4d15-82b2-0eaa91ca457212017-11-06
67544-996-62EA - Each67544-996ef239f39-4ca9-4128-a567-6a7338d343e912017-11-06