Diazepam

Product NDC
68788-9937
11-digit product format
687889937
Labeler code
68788
Product ID
68788-9937_595798c9-bf3a-456a-8e4e-9b3507f53608
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA077749
Marketing category
ANDA
Marketing start
2012-01-17
Marketing end
0000-00-00
Substance
DIAZEPAM
Active strength
5 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9937DDiscontinued by firm2026-08-03
excluded packagepackage68788-993768788-9937-0DDiscontinued by firm2026-08-03
excluded packagepackage68788-993768788-9937-1DDiscontinued by firm2026-08-03
excluded packagepackage68788-993768788-9937-2DDiscontinued by firm2026-08-03
excluded packagepackage68788-993768788-9937-3DDiscontinued by firm2026-08-03
excluded packagepackage68788-993768788-9937-4DDiscontinued by firm2026-08-03
excluded packagepackage68788-993768788-9937-5DDiscontinued by firm2026-08-03
excluded packagepackage68788-993768788-9937-6DDiscontinued by firm2026-08-03
excluded packagepackage68788-993768788-9937-8DDiscontinued by firm2026-08-03
excluded packagepackage68788-993768788-9937-9DDiscontinued 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 2 · 120 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 packagepackage68788-9937-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9937-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9937-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9937-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9937-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9937-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9937-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9937-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9937-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9937-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9937-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9937-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9937-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9937-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9937-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9937-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9937-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9937-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9937-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9937-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9937-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9937-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9937-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9937-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9937-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9937-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9937-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9937-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9937-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9937-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9937-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9937-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9937-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9937-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9937-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9937-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9937-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9937-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9937-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9937-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9937-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9937-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9937-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9937-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9937-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9937-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9937-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9937-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9937-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9937-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9937-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9937-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9937-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9937-2cdf11ea48f46…ba0047e9e063…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077749-001DIAZEPAMDIAZEPAM2MGTABLET / ORAL2006-03-31
A077749-002DIAZEPAMDIAZEPAM5MGTABLET / ORAL2006-03-31
A077749-003DIAZEPAMDIAZEPAM10MGTABLET / ORAL2006-03-31

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077749-001DIAZEPAM2MGTABLET / ORAL2006-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077749-002DIAZEPAM5MGTABLET / ORAL2006-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077749-003DIAZEPAM10MGTABLET / ORAL2006-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077749-001DIAZEPAM2MGTABLET / ORALAB2006-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077749-002DIAZEPAM5MGTABLET / ORALAB2006-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077749-003DIAZEPAM10MGTABLET / ORALAB2006-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077749-001DIAZEPAM2MGTABLET / ORALAB2006-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077749-002DIAZEPAM5MGTABLET / ORALAB2006-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077749-003DIAZEPAM10MGTABLET / ORALAB2006-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077749-001DIAZEPAM2MGTABLET / ORALAB2006-03-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077749-002DIAZEPAM5MGTABLET / ORALAB2006-03-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077749-003DIAZEPAM10MGTABLET / ORALAB2006-03-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077749-001DIAZEPAM2MGTABLET / ORALAB2006-03-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077749-002DIAZEPAM5MGTABLET / ORALAB2006-03-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077749-003DIAZEPAM10MGTABLET / ORALAB2006-03-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077749-001DIAZEPAM2MGTABLET / ORALAB2006-03-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077749-002DIAZEPAM5MGTABLET / ORALAB2006-03-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077749-003DIAZEPAM10MGTABLET / ORALAB2006-03-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077749-001DIAZEPAM2MGTABLET / ORALAB2006-03-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077749-002DIAZEPAM5MGTABLET / ORALAB2006-03-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077749-003DIAZEPAM10MGTABLET / ORALAB2006-03-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077749-001DIAZEPAM2MGTABLET / ORALAB2006-03-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077749-002DIAZEPAM5MGTABLET / ORALAB2006-03-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077749-003DIAZEPAM10MGTABLET / ORALAB2006-03-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077749-001DIAZEPAM2MGTABLET / ORALAB2006-03-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077749-002DIAZEPAM5MGTABLET / ORALAB2006-03-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077749-003DIAZEPAM10MGTABLET / ORALAB2006-03-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077749-001DIAZEPAM2MGTABLET / ORALAB2006-03-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A077749-002DIAZEPAM5MGTABLET / ORALAB2006-03-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A077749-003DIAZEPAM10MGTABLET / ORALAB2006-03-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077749-001DIAZEPAM2MGTABLET / ORALAB2006-03-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077749-002DIAZEPAM5MGTABLET / ORALAB2006-03-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077749-003DIAZEPAM10MGTABLET / ORALAB2006-03-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077749-001DIAZEPAM2MGTABLET / ORALAB2006-03-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077749-002DIAZEPAM5MGTABLET / ORALAB2006-03-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077749-003DIAZEPAM10MGTABLET / ORALAB2006-03-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077749-001DIAZEPAM2MGTABLET / ORALAB2006-03-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077749-002DIAZEPAM5MGTABLET / ORALAB2006-03-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077749-003DIAZEPAM10MGTABLET / ORALAB2006-03-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077749-001DIAZEPAM2MGTABLET / ORALAB2006-03-318072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077749-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077749-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077749-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077749-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077749-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077749-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077749-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077749-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077749-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077749-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077749-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077749-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077749-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077749-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077749-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077749-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077749-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077749-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077749-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077749-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077749-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077749-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077749-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077749-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077749-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077749-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077749-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077749-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077749-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077749-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077749-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077749-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077749-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077749-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077749-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077749-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077749-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077749-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077749-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077749-001AB15c6f7cd8ea54…