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 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 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.
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 2026-08-01 22:54:32 2026-06 A071583-001 DIAZEPAM 50MG/10ML (5MG/ML) INJECTABLE / INJECTION AP RS 1987-10-13 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A071583-001 AP 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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
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