Home NDC 13517-100 Diazoxide
Product NDC 13517-100
11-digit product format 135170100
Labeler code 13517
Product ID 13517-100_11c83c92-145b-486a-90f3-d759c358d091
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diazoxide
Dosage form SUSPENSION
Route ORAL
Labeler e5 Pharma, LLC
Application ANDA211050
Marketing category ANDA
Marketing start 2019-12-11
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 43 .
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 A211050-001 DIAZOXIDE DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211050-001 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 2026-09-14 22:38:34 2026-08 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211050-001 DIAZOXIDE 50MG/ML SUSPENSION / ORAL AB 2019-12-20 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2020-12-22 03:56 UTC 2020-12 A211050-001 CGT 2020-06-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211050-001 CGT 2020-06-17 c0c555d07b60…
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 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 13517-100-30 Diazoxide 30 mL in 1 BOTTLE, DROPPER SUSPENSION 30 12 13517-100-30 Diazoxide 1 in 1 CARTON SUSPENSION 1 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13517-100 DIAZOXIDE SUSPENSION [E5 PHARMA, LLC] 11 Current NDC, Legacy NDC, 2 package rows 20250213_c0237320-2d3f-4907-a4d3-08f138aa4ca8.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 · 1 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 13517-100-30 13517010030 1 BOTTLE, DROPPER in 1 CARTON (13517-100-30) / 30 mL in 1 BOTTLE, DROPPER 2019-12-11 0000-00-00 No No Current