Home NDC 76045-204 Diazepam
Product NDC 76045-204
11-digit product format 760450204
Labeler code 76045
Product ID 76045-204_c6b235b0-6b36-4e9b-a214-2b924f0d4126
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DIAZEPAM
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA214745
Marketing category ANDA
Marketing start 2022-11-10
Substance DIAZEPAM
Active strength 10 mg/2mL
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214745-001 DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214745-001 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.
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 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Diazepam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIAZEPAM 10 mg/2mL
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 2120550 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 76045-204-00 Diazepam 2 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 2 2 76045-204-20 Diazepam 24 in 1 CARTON INJECTION, SOLUTION 24 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76045-204 DIAZEPAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 Current NDC, Legacy NDC, 2 package rows 20230107_ae52866a-0b9a-4baf-af1b-f9d5e00c0e56.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76045-204-00 76045020400 2 mL in 1 SYRINGE, GLASS 2 ml Historical 76045-204-20 76045020420 24 SYRINGE, GLASS in 1 CARTON (76045-204-20) / 2 mL in 1 SYRINGE, GLASS (76045-204-00) 2022-11-10 0000-00-00 No No Current