Home NDC 25021-618 Diazepam
Product NDC 25021-618
11-digit product format 250210618
Labeler code 25021
Product ID 25021-618_ab45bb85-7915-4e85-8090-1efae274ba18
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diazepam
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA218450
Marketing category ANDA
Marketing start 2026-02-15
Substance DIAZEPAM
Active strength 5 mg/mL
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 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 A218450-001 DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-04-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218450-001 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 A218450-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218450-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218450-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218450-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218450-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218450-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218450-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218450-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218450-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218450-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218450-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218450-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218450-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218450-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-04-25 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218450-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-04-25 a50c72e98297…
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 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 25021-618-72 Diazepam 2 mL in 1 SYRINGE INJECTION, SOLUTION 2 1 25021-618-72 Diazepam 10 in 1 CARTON INJECTION, SOLUTION 10 1
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diazepam DIAZEPAM REMEDYREPACK INC. b4a045e4-d6ce-475d-abe4-590941bd3815 2026-07-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 218450 application number: ANDA218450 Diazepam DIAZEPAM Sagent Pharmaceuticals 7a912f1a-deee-46df-a8df-22a0afb06529 2026-02-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 218450 application number: ANDA218450 ndc (product): 25021-618 Diazepam DIAZEPAM Alembic Pharmaceuticals Inc. 6b6ca65b-4ede-47b9-bbf3-05bb67c0c71d 2024-04-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 218450 application number: ANDA218450 Diazepam DIAZEPAM Alembic Pharmaceuticals Limited 1632f040-3b2c-43da-a42f-f2baf5ec778a 2024-04-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 218450 application number: ANDA218450
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 25021-618-72 25021061872 10 SYRINGE in 1 CARTON (25021-618-72) / 2 mL in 1 SYRINGE 10 syringe 2026-02-15 No No Current