DIAZEPAM

Product NDC
61919-071
11-digit product format
619190071
Labeler code
61919
Product ID
61919-071_9238dcea-d909-c1e3-e053-2a95a90aeef9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIAZEPAM
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077749
Marketing category
ANDA
Marketing start
2014-01-01
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
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-071IInactivated by FDA2026-08-03
excluded packagepackage61919-07161919-071-10IInactivated by FDA2026-08-03
excluded packagepackage61919-07161919-071-30IInactivated 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 · 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 packagepackage61919-071-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-071-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-071-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-071-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-071-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-071-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-071-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-071-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-071-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-071-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-071-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-071-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-071-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-071-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-071-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-071-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-071-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-071-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-071-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-071-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-071-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-071-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-071-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-071-10557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-071-308af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-071-108af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-071-30834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-071-10834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-071-301332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-071-101332a3947898…d4bfe170f9cd…

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…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-071-102023-01-30C16284748780-1f386c649-c329-0266-e053-dadaa90a7c1aDIAZEPAM
61919-071-302023-01-30C16284748780-1f386c649-c329-0266-e053-dadaa90a7c1aDIAZEPAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-071-10DIAZEPAM10 in 1 BOTTLETABLET104
61919-071-20DIAZEPAM20 in 1 BOTTLETABLET204
61919-071-30DIAZEPAM30 in 1 BOTTLETABLET304
61919-071-60DIAZEPAM60 in 1 BOTTLETABLET604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-071-20EA - Each61919-0715419f074-ea02-4ce2-af60-f474d9eb1de912015-10-02
61919-071-30EA - Each61919-071855e2841-b6f8-4d1c-97ac-98a7ecefc09412015-10-02
61919-071-60EA - Each61919-0712824df01-89f7-4fc1-9cf1-63ccd5ce5ef312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [DIRECT RX]2
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [DIRECT RX]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LDIAZEPAM TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [DIRECT RX]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIAZEPAM TABLET [DIRECT RX]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIAZEPAM TABLET [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-071DIAZEPAM TABLET [DIRECT RX]4Legacy NDC, 4 package rows20190911_0952dd80-819c-424e-9a82-eb161c02af4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSN0952dd80-819c-424e-9a82-eb161c02af4d4
197589diazepam 10 MG Oral TabletSCD0952dd80-819c-424e-9a82-eb161c02af4d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-071-106191900711010 TABLET in 1 BOTTLE (61919-071-10) 10 tablet2014-01-010000-00-00NoNoCurrent
61919-071-206191900712020 in 1 BOTTLEHistorical
61919-071-306191900713030 BOTTLE in 1 BOTTLE (61919-071-30) > 20 BOTTLE in 1 BOTTLE (61919-071-20) > 60 TABLET in 1 BOTTLE (61919-071-60) 30 bottle2019-09-100000-00-00NoNoCurrent
61919-071-606191900716060 in 1 BOTTLEHistorical