Diazepam

Product NDC
51862-063
Requested package NDC
51862-063-10
11-digit product format
518620063
Labeler code
51862
Product ID
51862-063_39fac1ad-f2d5-4fab-87c2-0c133b7fd641
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Mayne Pharma
Application
ANDA071135
Marketing category
ANDA
Marketing start
2016-08-03
Marketing end
2021-07-31
Substance
DIAZEPAM
Active strength
5 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage51862-06351862-063-10DDiscontinued 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 · 12 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…

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
A071135-001DIAZEPAMDIAZEPAM5MGTABLET / 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
A071135-001AB

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 22:38:342026-08A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-0384e616aacf4f…
2026-08-18 06:07:402026-07A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-033f01610625f2…
2019-09-15 20:21 UTC2019-09A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071135-001DIAZEPAM5MGTABLET / ORALAB1987-02-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071135-001DIAZEPAM5MGTABLET / 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 22:38:342026-08A071135-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A071135-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071135-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071135-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071135-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071135-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071135-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071135-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071135-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071135-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071135-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071135-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071135-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071135-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071135-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071135-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071135-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071135-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071135-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071135-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071135-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071135-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071135-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071135-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071135-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071135-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071135-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071135-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071135-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071135-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071135-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071135-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071135-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071135-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071135-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071135-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071135-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071135-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071135-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071135-001AB1f41ea6bd6efb…

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
51862-063-01EA - Each51862-0634362716a-8cca-4ec1-bf16-30baf34a62f412016-09-02
51862-063-05EA - Each51862-0633581b3a1-1a4f-4ca3-aa18-2c397e4c26eb12016-09-02
51862-063-10EA - Each51862-063c34c8b9f-f567-4401-9c93-19c4e8f14ea012016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [MAJOR PHARMACEUTICALS]7
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [MAJOR PHARMACEUTICALS]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIAZEPAM TABLET [MAJOR PHARMACEUTICALS]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [MAJOR PHARMACEUTICALS]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIAZEPAM TABLET [MAJOR PHARMACEUTICALS]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [MAJOR PHARMACEUTICALS]7

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197591diazePAM 5 MG Oral TabletPSN718c0dfc-15f9-92e0-e053-2995a90a30513
197591diazePAM 5 MG Oral TabletPSNc1b09bf1-efbb-4773-bacd-e522a33eb3733
197591diazepam 5 MG Oral TabletSCD718c0dfc-15f9-92e0-e053-2995a90a30513
197591diazepam 5 MG Oral TabletSCDc1b09bf1-efbb-4773-bacd-e522a33eb3733
197589diazePAM 10 MG Oral TabletPSN58af1a75-4acb-0506-e053-2991aa0a738f2
197591diazePAM 5 MG Oral TabletPSN50377b7a-6fb4-43f2-e054-00144ff8d46c2
197591diazePAM 5 MG Oral TabletPSN58af1a75-4acb-0506-e053-2991aa0a738f2
197591diazePAM 5 MG Oral TabletPSN8d573383-ff68-5771-e053-2a95a90acdf42
197589diazepam 10 MG Oral TabletSCD58af1a75-4acb-0506-e053-2991aa0a738f2
197591diazepam 5 MG Oral TabletSCD50377b7a-6fb4-43f2-e054-00144ff8d46c2
197591diazepam 5 MG Oral TabletSCD58af1a75-4acb-0506-e053-2991aa0a738f2
197591diazepam 5 MG Oral TabletSCD8d573383-ff68-5771-e053-2a95a90acdf42
197591diazePAM 5 MG Oral TabletPSN4a2a1a9d-1ebd-5b90-e054-00144ff8d46c1
197591diazePAM 5 MG Oral TabletPSN8d564803-7f5a-a2dc-e053-2a95a90a30d91
197591diazepam 5 MG Oral TabletSCD4a2a1a9d-1ebd-5b90-e054-00144ff8d46c1
197591diazepam 5 MG Oral TabletSCD8d564803-7f5a-a2dc-e053-2a95a90a30d91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-063-10518620063101000 TABLET in 1 BOTTLE, PLASTIC (51862-063-10) 1000 tablet2016-08-032021-07-31NoNoCurrent