Diazepam

Product NDC
67046-945
Requested package NDC
67046-945-21
11-digit product format
670460945
Labeler code
67046
Product ID
67046-945_59b78f7b-5cd2-2a69-e053-2a91aa0aa5e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA071307
Marketing category
ANDA
Marketing start
2017-09-21
Marketing end
0000-00-00
Substance
DIAZEPAM
Active strength
2 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67046-94567046-945-21IInactivated by FDA2026-08-03

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 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
A071307-001DIAZEPAMDIAZEPAM2MGTABLET / 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
A071307-001AB

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 UTC2026-02A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071307-001DIAZEPAM2MGTABLET / ORALAB1986-12-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071307-001DIAZEPAM2MGTABLET / 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 UTC2026-02A071307-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071307-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071307-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071307-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071307-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071307-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071307-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071307-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071307-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071307-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071307-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071307-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071307-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071307-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071307-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071307-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071307-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071307-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071307-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071307-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071307-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071307-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071307-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071307-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071307-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071307-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071307-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071307-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071307-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071307-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071307-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071307-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071307-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071307-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071307-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071307-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071307-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071307-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071307-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071307-001AB1cb3db0bc1861…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-945-07Diazepam7 in 1 BLISTER PACKTABLET71
67046-945-14Diazepam14 in 1 BLISTER PACKTABLET141
67046-945-15Diazepam15 in 1 BLISTER PACKTABLET151
67046-945-20Diazepam20 in 1 BLISTER PACKTABLET201
67046-945-21Diazepam21 in 1 BLISTER PACKTABLET211
67046-945-28Diazepam28 in 1 BLISTER PACKTABLET281
67046-945-30Diazepam30 in 1 BLISTER PACKTABLET301
67046-945-60Diazepam60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-945DIAZEPAM TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170921_59b78f7b-5cd1-2a69-e053-2a91aa0aa5e2.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.1ad84940-40f7-457a-8ffa-53e1a7bfee162025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071307
application number: ANDA071307
DiazepamDIAZEPAMA-S Medication Solutionsec433be5-d84d-425f-9edf-71263f885eec2025-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071307
application number: ANDA071307
DiazepamDIAZEPAMAsclemed USA, Inc.32e7bfa1-6060-4041-a0e5-249cacb84ebc2025-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071307
application number: ANDA071307
DiazepamDIAZEPAMBryant Ranch Prepack04cc10ad-7d5c-434e-9b29-85b14071492b2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071307
application number: ANDA071307
DiazepamDIAZEPAMTeva Pharmaceuticals USA, Inc.48aa32cb-047a-414a-822e-82a5f26d88172024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071307
application number: ANDA071307
DiazepamDIAZEPAMClinical Solutions Wholesale, LLC83c1f93b-0fc6-4512-9c8f-9167b217d7f92024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071307
application number: ANDA071307
DiazepamDIAZEPAMAphena Pharma Solutions - Tennessee, LLCb29916fb-1781-4112-9c3e-45478754d6382017-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071307
application number: ANDA071307

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSN59b78f7b-5cd1-2a69-e053-2a91aa0aa5e21
197590diazePAM 2 MG Oral TabletPSN59b78f7b-5cd1-2a69-e053-2a91aa0aa5e21
197591diazePAM 5 MG Oral TabletPSN59b78f7b-5cd1-2a69-e053-2a91aa0aa5e21
197589diazepam 10 MG Oral TabletSCD59b78f7b-5cd1-2a69-e053-2a91aa0aa5e21
197590diazepam 2 MG Oral TabletSCD59b78f7b-5cd1-2a69-e053-2a91aa0aa5e21
197591diazepam 5 MG Oral TabletSCD59b78f7b-5cd1-2a69-e053-2a91aa0aa5e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-945-216704609452121 TABLET in 1 BLISTER PACK (67046-945-21) 21 tablet2017-09-210000-00-00NoNoCurrent