Diazepam

Product NDC
68788-9207
11-digit product format
687889207
Labeler code
68788
Product ID
68788-9207_b917cdf5-0881-4503-ba5c-a9a4fcae95a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA071322
Marketing category
ANDA
Marketing start
2011-11-09
Marketing end
0000-00-00
Substance
DIAZEPAM
Active strength
10 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct68788-9207DDiscontinued by firm2026-08-10
excluded packagepackage68788-920768788-9207-0DDiscontinued by firm2026-08-10
excluded packagepackage68788-920768788-9207-1DDiscontinued by firm2026-08-10
excluded packagepackage68788-920768788-9207-2DDiscontinued by firm2026-08-10
excluded packagepackage68788-920768788-9207-3DDiscontinued by firm2026-08-10
excluded packagepackage68788-920768788-9207-4DDiscontinued by firm2026-08-10
excluded packagepackage68788-920768788-9207-5DDiscontinued by firm2026-08-10
excluded packagepackage68788-920768788-9207-6DDiscontinued by firm2026-08-10
excluded packagepackage68788-920768788-9207-8DDiscontinued by firm2026-08-10
excluded packagepackage68788-920768788-9207-9DDiscontinued by firm2026-08-10

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 · 50 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 packagepackage68788-9207-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9207-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9207-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9207-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9207-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9207-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9207-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9207-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9207-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9207-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9207-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9207-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9207-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9207-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9207-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9207-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9207-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9207-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9207-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9207-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9207-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9207-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9207-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9207-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9207-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9207-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9207-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9207-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9207-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9207-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9207-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9207-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9207-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9207-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9207-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9207-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9207-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9207-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9207-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9207-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9207-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9207-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9207-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9207-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9207-0cfe11265f3b6…090c488252e2…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071322-001DIAZEPAMDIAZEPAM10MGTABLET / ORALAB1986-12-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A071322-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071322-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071322-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071322-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071322-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071322-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071322-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071322-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071322-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071322-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071322-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071322-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071322-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071322-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071322-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071322-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071322-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071322-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071322-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071322-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071322-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071322-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071322-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071322-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071322-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071322-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071322-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071322-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071322-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071322-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071322-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071322-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071322-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071322-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071322-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071322-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071322-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071322-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071322-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071322-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071322-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
69057c52-36b0-21c0-02d6-d697be15c03cProduct name420260305
da74e203-d183-4c62-8511-c3ef56b5964eProduct name120250213
2792dd44-ff30-4712-8b05-1850c2b4d307Product name320250211
2fd3ebb9-86c1-64e3-e9b6-3c2ba01c6876Product name220250102
0f898f8b-23f1-b816-6bfe-c7f8aac7e42bProduct name220240529
2c487d7e-cbfc-4699-9c83-5c1c7521cde9Product name120200610
02ac201d-7ee6-00c9-f963-81bb5a506b68Product name320160816

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-9207-2Diazepam20 in 1 BOTTLETABLET202
68788-9207-3Diazepam30 in 1 BOTTLETABLET302
68788-9207-6Diazepam60 in 1 BOTTLETABLET602
68788-9207-9Diazepam90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-9207-0EA - Each68788-9207bb355c05-5ba8-465e-82e7-5ff234a4dfff12022-10-06
68788-9207-1EA - Each68788-9207873a14f1-b5ca-4c85-8316-7a6e1080ffb812022-10-06
68788-9207-2EA - Each68788-9207abf19ba1-9013-4989-a9ce-bf9657bdf2a612022-10-06
68788-9207-3EA - Each68788-920794c134ab-1e03-425e-b3c1-6ece235259ba12022-10-06
68788-9207-4EA - Each68788-920719c0d83d-7868-4688-b9fc-1de3561a879312022-10-06
68788-9207-5EA - Each68788-920702a4d054-c6fb-494f-8768-a3b986cc0d1b12022-10-06
68788-9207-6EA - Each68788-92070cdc60e3-7f54-48d4-8fd0-aee604175efe12022-09-12
68788-9207-8EA - Each68788-92073bb9b277-0e65-40bd-b77b-3cdb40b80e7a12022-09-12
68788-9207-9EA - Each68788-92078c2c4f07-d5bf-4324-b129-b705cbf9032a12022-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]6
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]6
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]6
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9207DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2Legacy NDC, 4 package rows20130727_e5f4151c-ee35-4ff7-8374-ab202642373c.zip

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAMREMEDYREPACK INC.5ebef149-1858-4199-aaed-7b9341fae63d2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMCoupler LLC5111654f-a026-71b2-e063-6294a90ab49b2026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMREMEDYREPACK INC.d7a4b3c7-7021-4764-8c21-49e4bc6f60582026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DIAZEPAMDIAZEPAMDirect_Rx4b0c9c0a-4274-4d56-a7a4-bc497916469c2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.84cecab3-d0e6-436b-996b-0b598e9723082025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMA-S Medication Solutionsb47dc708-e83b-4224-bdb5-c9b7abd35cfb2025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMAsclemed USA, Inc.32e7bfa1-6060-4041-a0e5-249cacb84ebc2025-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMAdvanced Rx Pharmacy of Tennessee, LLCb7002d26-3856-4c2f-e053-2995a90aea602024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMNuCare Pharmaceuticals,Inc.859461ea-5861-8185-e053-2991aa0a954a2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMBryant Ranch Prepack078bbb41-7e3a-48db-87f0-ec6a6ec0194e2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMTeva Pharmaceuticals USA, Inc.48aa32cb-047a-414a-822e-82a5f26d88172024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMAphena Pharma Solutions - Tennessee, LLC9cf031ae-d59b-430d-9b15-415ae2e49c982022-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMProficient Rx LPf8d26f65-a015-4bfc-b1fa-8595d72af48c2022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSNe5f4151c-ee35-4ff7-8374-ab202642373c2
197589diazepam 10 MG Oral TabletSCDe5f4151c-ee35-4ff7-8374-ab202642373c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-9207-0687889207002 TABLET in 1 BOTTLE (68788-9207-0) 2 tablet2011-11-090000-00-00NoNoCurrent
68788-9207-16878892070115 TABLET in 1 BOTTLE (68788-9207-1) 15 tablet2011-11-090000-00-00NoNoCurrent
68788-9207-26878892070220 TABLET in 1 BOTTLE (68788-9207-2) 20 tablet2011-11-090000-00-00NoNoCurrent
68788-9207-36878892070330 TABLET in 1 BOTTLE (68788-9207-3) 30 tablet2011-11-090000-00-00NoNoCurrent
68788-9207-46878892070410 TABLET in 1 BOTTLE (68788-9207-4) 10 tablet2011-11-090000-00-00NoNoCurrent
68788-9207-5687889207056 TABLET in 1 BOTTLE (68788-9207-5) 6 tablet2011-11-090000-00-00NoNoCurrent
68788-9207-66878892070660 TABLET in 1 BOTTLE (68788-9207-6) 60 tablet2011-11-090000-00-00NoNoCurrent
68788-9207-868788920708100 TABLET in 1 BOTTLE (68788-9207-8) 100 tablet2011-11-090000-00-00NoNoCurrent
68788-9207-96878892070990 TABLET in 1 BOTTLE (68788-9207-9) 90 tablet2011-11-090000-00-00NoNoCurrent