Home NDC 0254-1010 Diazoxide
Product NDC 0254-1010
11-digit product format 002541010
Labeler code 0254
Product ID 0254-1010_ca21c9b7-669a-4f0f-afe0-0b166c13bb98
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diazoxide
Dosage form SUSPENSION
Route ORAL
Labeler Par Health USA, LLC
Application ANDA210799
Marketing category ANDA
Marketing start 2020-07-21
Substance DIAZOXIDE
Active strength 50 mg/mL
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 A210799-001 DIAZOXIDE DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2020-07-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210799-001 AB
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 A210799-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2020-07-08 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 A210799-001 AB 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Diazoxide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIAZOXIDE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O5CB12L4FN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197593 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 0254-1010-19 Diazoxide 30 mL in 1 BOTTLE, DROPPER SUSPENSION 30 7 0254-1010-19 Diazoxide 1 in 1 CARTON SUSPENSION 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0254-1010 DIAZOXIDE SUSPENSION [ENDO USA, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20240913_abe317a5-6c63-469c-89c8-9fedfe859c3d.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 0254-1010-19 00254101019 1 BOTTLE, DROPPER in 1 CARTON (0254-1010-19) / 30 mL in 1 BOTTLE, DROPPER 2020-07-21 0000-00-00 No No Current