Home NDC 0404-9848 Diazepam
Product NDC 0404-9848
11-digit product format 004049848
Labeler code 0404
Product ID 0404-9848_eb7ae780-68a5-4462-9822-3fe66678f967
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diazepam
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Henry Schein, Inc.
Application ANDA071583
Marketing category ANDA
Marketing start 2022-01-10
Marketing end 2026-12-31
Substance DIAZEPAM
Active strength 5 mg/mL
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071583-001 DIAZEPAM DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071583-001 AP
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 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION RS 1987-10-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION RS 1987-10-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION RS 1987-10-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION RS 1987-10-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Diazepam Active Ingredients# Ingredient, Strength table Ingredient Strength DIAZEPAM 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q3JTX2Q7TU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309845 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0404-9848-10 Diazepam 1 in 1 BAG INJECTION, SOLUTION 1 7 0404-9848-10 Diazepam 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9848 DIAZEPAM (DIAZEPAM) INJECTION, SOLUTION [HENRY SCHEIN, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240727_bfa85a63-967f-4176-a752-0bafabbaaae3.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diazepam DIAZEPAM Hospira, Inc. 7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f 2026-05-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071583 application number: ANDA071583 Diazepam DIAZEPAM Henry Schein, Inc. bfa85a63-967f-4176-a752-0bafabbaaae3 2026-02-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071583 application number: ANDA071583 ndc (product): 0404-9848 Diazepam DIAZEPAM Medical Purchasing Solutions, LLC c8e979a8-af6b-f0c4-e053-2995a90ae63f 2023-05-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 071583 application number: ANDA071583
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0404-9848-10 00404984810 1 VIAL, MULTI-DOSE in 1 BAG (0404-9848-10) / 10 mL in 1 VIAL, MULTI-DOSE 2022-01-10 2026-12-31 No No Current