Diazepam

Product NDC
71335-0444
11-digit product format
713350444
Labeler code
71335
Product ID
71335-0444_5f5a6893-926b-4934-bdcd-b1c0efedf319
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA071322
Marketing category
ANDA
Marketing start
1986-12-10
Substance
DIAZEPAM
Active strength
10 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Diazepam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZEPAM10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q3JTX2Q7TUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197589Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
078bbb41-7e3a-48db-87f0-ec6a6ec0194eAvailable on FDA.report

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
71335-0444-0Diazepam56 in 1 BOTTLETABLET5612
71335-0444-1Diazepam20 in 1 BOTTLETABLET2012
71335-0444-2Diazepam30 in 1 BOTTLETABLET3012
71335-0444-3Diazepam40 in 1 BOTTLETABLET4012
71335-0444-4Diazepam50 in 1 BOTTLETABLET5012
71335-0444-5Diazepam60 in 1 BOTTLETABLET6012
71335-0444-6Diazepam90 in 1 BOTTLETABLET9012
71335-0444-7Diazepam100 in 1 BOTTLETABLET10012
71335-0444-8Diazepam10 in 1 BOTTLETABLET1012
71335-0444-9Diazepam120 in 1 BOTTLETABLET12012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0444-0EA - Each71335-04441f5bb8ba-f185-4952-adf4-43e900a497e312018-03-08
71335-0444-1EA - Each71335-0444531312a7-a648-4697-b6fc-2ac65651943c12018-03-08
71335-0444-2EA - Each71335-044429276ef5-6eed-4a60-a0fb-cd06823e3dca12018-03-08
71335-0444-3EA - Each71335-044446ae24e9-7cca-462d-b53b-db0f01a4aa0612018-03-08
71335-0444-4EA - Each71335-0444f5293a39-6070-48ca-89a0-c15d169db99112018-03-08
71335-0444-5EA - Each71335-044482e0b386-9f29-46f4-9d9b-083cd7c662bf12018-03-08
71335-0444-6EA - Each71335-04441b5aee7e-8410-4be4-9d79-2b6f8dae446b12018-03-08
71335-0444-7EA - Each71335-0444031abc66-a33b-4702-9077-2f2b0edb066512018-03-08
71335-0444-8EA - Each71335-04444f708628-c265-422a-a012-9aa5f5d0232b12018-03-08
71335-0444-9EA - Each71335-044476973ba7-46de-4b36-b440-b08a82b12f1612018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0444DIAZEPAM TABLET [BRYANT RANCH PREPACK]12Current NDC, Legacy NDC, 10 package rows20240417_078bbb41-7e3a-48db-87f0-ec6a6ec0194e.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
ndc (product): 71335-0444
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 TabletPSN078bbb41-7e3a-48db-87f0-ec6a6ec0194e12
197589diazepam 10 MG Oral TabletSCD078bbb41-7e3a-48db-87f0-ec6a6ec0194e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0444-07133504440056 TABLET in 1 BOTTLE (71335-0444-0) 56 tablet2024-04-030000-00-00NoNoCurrent
71335-0444-17133504440120 TABLET in 1 BOTTLE (71335-0444-1) 20 tablet2019-07-260000-00-00NoNoCurrent
71335-0444-27133504440230 TABLET in 1 BOTTLE (71335-0444-2) 30 tablet2018-02-140000-00-00NoNoCurrent
71335-0444-37133504440340 TABLET in 1 BOTTLE (71335-0444-3) 40 tablet2018-02-270000-00-00NoNoCurrent
71335-0444-47133504440450 TABLET in 1 BOTTLE (71335-0444-4) 50 tablet2024-04-030000-00-00NoNoCurrent
71335-0444-57133504440560 TABLET in 1 BOTTLE (71335-0444-5) 60 tablet2018-02-190000-00-00NoNoCurrent
71335-0444-67133504440690 TABLET in 1 BOTTLE (71335-0444-6) 90 tablet2018-03-060000-00-00NoNoCurrent
71335-0444-771335044407100 TABLET in 1 BOTTLE (71335-0444-7) 100 tablet2024-04-030000-00-00NoNoCurrent
71335-0444-87133504440810 TABLET in 1 BOTTLE (71335-0444-8) 10 tablet2019-03-250000-00-00NoNoCurrent
71335-0444-971335044409120 TABLET in 1 BOTTLE (71335-0444-9) 120 tablet2018-07-230000-00-00NoNoCurrent