Home NDC 76045-204 Diazepam
Product NDC 76045-204
11-digit product format 760450204
Labeler code 76045
Product ID 76045-204_91cde8d1-6c22-421d-96d5-40271e612876
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 2026-11-14 07:37:17 2026-10 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214745-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2022-11-10 caaa826d4ba7…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Diazepam
Listing expiration 2027-12-31 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
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