Home NDC 0641-6243 Diazepam
Product NDC 0641-6243
11-digit product format 006416243
Labeler code 0641
Product ID 0641-6243_19d85848-918f-4abb-b835-ff0679457d8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diazepam
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA070311
Marketing category ANDA
Marketing start 1985-12-16
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070311-001 DIAZEPAM DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP 1985-12-16 A070311-002 DIAZEPAM DIAZEPAM 5MG/ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 A070311-003 DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070311-001 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 · 75 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 2026-02-19 14:30 UTC 2026-02 A070311-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP 1985-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070311-002 DIAZEPAM 5MG/ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070311-003 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070311-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP 1985-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070311-002 DIAZEPAM 5MG/ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070311-003 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070311-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP 1985-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070311-002 DIAZEPAM 5MG/ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070311-003 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070311-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP 1985-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070311-002 DIAZEPAM 5MG/ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070311-003 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070311-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP 1985-12-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070311-002 DIAZEPAM 5MG/ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070311-003 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070311-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP 1985-12-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070311-002 DIAZEPAM 5MG/ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070311-003 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070311-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP 1985-12-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070311-002 DIAZEPAM 5MG/ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070311-003 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070311-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP 1985-12-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070311-002 DIAZEPAM 5MG/ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070311-003 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070311-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP 1985-12-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070311-002 DIAZEPAM 5MG/ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070311-003 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070311-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP 1985-12-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A070311-002 DIAZEPAM 5MG/ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A070311-003 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070311-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP 1985-12-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070311-002 DIAZEPAM 5MG/ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070311-003 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070311-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP 1985-12-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070311-002 DIAZEPAM 5MG/ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070311-003 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070311-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP 1985-12-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070311-002 DIAZEPAM 5MG/ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070311-003 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION 1985-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070311-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP 1985-12-16 8072bd15b7f6…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Diazepam
Listing expiration 2027-12-31 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 0641-6243-10 Diazepam 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 4 0641-6243-10 Diazepam 10 in 1 CARTON INJECTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6243 DIAZEPAM INJECTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, 2 package rows 20241121_f466f8a3-f31c-44f4-b0e8-444464f20f66.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0641-6243-10 00641624310 10 VIAL, MULTI-DOSE in 1 CARTON (0641-6243-10) / 10 mL in 1 VIAL, MULTI-DOSE 1985-12-16 No No Current