Diazepam

Product NDC
51862-943
11-digit product format
518620943
Labeler code
51862
Product ID
51862-943_8b4e541d-45c8-4bd2-a109-4551dfed8154
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Mayne Pharma
Application
ANDA071136
Marketing category
ANDA
Marketing start
2019-10-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51862-943DDiscontinued by firm2026-10-05
excluded packagepackage51862-94351862-943-01DDiscontinued by firm2026-10-05
excluded packagepackage51862-94351862-943-05DDiscontinued by firm2026-10-05
excluded packagepackage51862-94351862-943-10DDiscontinued by firm2026-10-05

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 · 45 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 packagepackage51862-943-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51862-943-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51862-943-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51862-943-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51862-943-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51862-943-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51862-943-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51862-943-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51862-943-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51862-943-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51862-943-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51862-943-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51862-943-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51862-943-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51862-943-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51862-943-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51862-943-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51862-943-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51862-943-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51862-943-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51862-943-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51862-943-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51862-943-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51862-943-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51862-943-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51862-943-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51862-943-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51862-943-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51862-943-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51862-943-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51862-943-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51862-943-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51862-943-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51862-943-10557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A071136-001DIAZEPAMDIAZEPAM10MGTABLET / ORALAB1987-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071136-001AB

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-0384e616aacf4f…
2026-08-18 06:07:402026-07A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-033f01610625f2…
2019-09-15 20:21 UTC2019-09A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071136-001DIAZEPAM10MGTABLET / ORALAB1987-02-03f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A071136-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A071136-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071136-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071136-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071136-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071136-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071136-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071136-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071136-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071136-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071136-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071136-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071136-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071136-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071136-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071136-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071136-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071136-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071136-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071136-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071136-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071136-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071136-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071136-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071136-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071136-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071136-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071136-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071136-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071136-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071136-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071136-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071136-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071136-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071136-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071136-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071136-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071136-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071136-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071136-001AB1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-943-01EA - Each51862-9435e157f06-8ee6-4fee-8561-99ac564678b312019-12-10
51862-943-05EA - Each51862-943f2d49af9-1b70-442c-b289-2d09030855bf12019-12-10
51862-943-10EA - Each51862-94377d127ef-8945-4880-95ec-a1b5ac5a907d12019-12-10

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSN7d76cfb9-2e00-4a48-ac88-ae4b7d1132e4102
197589diazepam 10 MG Oral TabletSCD7d76cfb9-2e00-4a48-ac88-ae4b7d1132e4102
197589diazePAM 10 MG Oral TabletPSNef19c847-2af4-ba07-e053-2995a90a9aa24
197589diazepam 10 MG Oral TabletSCDef19c847-2af4-ba07-e053-2995a90a9aa24
197589diazePAM 10 MG Oral TabletPSNafdf1b5c-1030-7742-e053-2a95a90a6dec1
197589diazepam 10 MG Oral TabletSCDafdf1b5c-1030-7742-e053-2a95a90a6dec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-943-0151862094301100 TABLET in 1 BOTTLE, PLASTIC (51862-943-01) 100 tablet2019-10-310000-00-00NoNoCurrent
51862-943-0551862094305500 TABLET in 1 BOTTLE, PLASTIC (51862-943-05) 500 tablet2019-10-310000-00-00NoNoCurrent
51862-943-10518620943101000 TABLET in 1 BOTTLE, PLASTIC (51862-943-10) 1000 tablet2019-10-310000-00-00NoNoCurrent