Diazepam

Product NDC
71872-7260
11-digit product format
718727260
Labeler code
71872
Product ID
71872-7260_facc396f-5544-33fd-e053-6394a90a1d6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIAZEPAM
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA071583
Marketing category
ANDA
Marketing start
2007-10-05
Substance
DIAZEPAM
Active strength
5 mg/mL
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
A071583-001DIAZEPAMDIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071583-001AP

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 UTC2026-02A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONRS1987-10-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONRS1987-10-133f01610625f2…
2019-09-15 20:21 UTC2019-09A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONRS1987-10-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONRS1987-10-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071583-001DIAZEPAM50MG/10ML (5MG/ML)INJECTABLE / INJECTIONAPRS1987-10-13cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071583-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071583-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071583-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071583-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071583-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071583-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071583-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071583-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071583-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071583-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071583-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071583-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071583-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071583-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071583-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071583-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071583-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A071583-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071583-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071583-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A071583-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071583-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071583-001AP1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071583-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071583-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071583-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071583-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071583-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071583-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071583-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071583-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071583-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071583-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071583-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071583-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071583-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A071583-001AP1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZEPAM5 mg/mL

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
309845Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c8e979a8-af6b-f0c4-e053-2995a90ae63fAvailable 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
2c487d7e-cbfc-4699-9c83-5c1c7521cde9Product name120200610
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
02ac201d-7ee6-00c9-f963-81bb5a506b68Product name320160816

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7260-1Diazepam10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION102
71872-7260-1Diazepam1 in 1 BAGINJECTION, SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7260DIAZEPAM INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Current NDC, Legacy NDC, 2 package rows20230504_c8e979a8-af6b-f0c4-e053-2995a90ae63f.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAMHospira, Inc.7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071583
application number: ANDA071583
DiazepamDIAZEPAMHenry Schein, Inc.bfa85a63-967f-4176-a752-0bafabbaaae32026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071583
application number: ANDA071583
DiazepamDIAZEPAMMedical Purchasing Solutions, LLCc8e979a8-af6b-f0c4-e053-2995a90ae63f2023-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071583
application number: ANDA071583
ndc (product): 71872-7260

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309845diazePAM 5 MG/ML Injectable SolutionPSNc8e979a8-af6b-f0c4-e053-2995a90ae63f2
309845diazepam 5 MG/ML Injectable SolutionSCDc8e979a8-af6b-f0c4-e053-2995a90ae63f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71872-7260-1718727260011 VIAL, MULTI-DOSE in 1 BAG (71872-7260-1) / 10 mL in 1 VIAL, MULTI-DOSE2021-07-070000-00-00NoNoCurrent