Home NDC 43598-106-10 Diazepam
Product NDC 43598-106
Requested package NDC 43598-106-10
11-digit product format 435980106
Labeler code 43598
Product ID 43598-106_429d0ffe-9774-b285-8534-bb76611da385
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DIAZEPAM
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Dr. Reddy's Laboratories Inc
Application ANDA218422
Marketing category ANDA
Marketing start 2024-08-07
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 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 A218422-001 DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-07-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218422-001 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 A218422-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218422-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218422-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-07-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218422-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-07-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218422-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-07-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218422-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-07-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218422-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-07-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218422-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-07-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218422-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-07-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218422-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-07-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218422-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-07-18 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218422-001 DIAZEPAM 10MG/2ML (5MG/ML) INJECTABLE / INJECTION AP 2024-07-18 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 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 43598-106-10 Diazepam 10 in 1 CARTON INJECTION, SOLUTION 10 4 43598-106-11 Diazepam 2 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 2 4 43598-106-11 Diazepam 2 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 2 1 43598-106-58 Diazepam 10 in 1 CARTON INJECTION, SOLUTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-106 DIAZEPAM INJECTION, SOLUTION [DR. REDDY'S LABORATORIES INC] 4 Current NDC, 2 package rows 20240810_2a633cef-6dfc-4186-b595-174db2d8330e.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 Marketing end Sample Exclude flag Status 43598-106-10 43598010610 10 SYRINGE, GLASS in 1 CARTON (43598-106-10) / 2 mL in 1 SYRINGE, GLASS (43598-106-11) 2024-08-07 2027-07-23 No No Historical