Diazoxide Oral Solution

Manufacturer: TriRx Huntsville Pharmaceutical Services LLC | TriRx Huntsville Pharmaceutical Services, LLC
Effective date: 2023-01-05
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-01 21:41:20

Label at a glance#

ProductDiazoxide Oral Solution

Active ingredientDIAZOXIDE

Label structure23 sections

Label contents#

Full prescribing information#

ANIMAL PHARMACOLOGY & OR TOXICOLOGY SECTION

animal Pharmacology/Toxicology

DESCRIPTION SECTION

Description

INDICATIONS & USAGE SECTION

Indications and Usage

CONTRAINDICATIONS SECTION

Contraindications

WARNINGS SECTION

Warnings

PRECAUTIONS SECTION

Precautions

precautions 2

LABORATORY TESTS SECTION

Laboratory Tests

DRUG INTERACTIONS SECTION

Drug Interactions

CLINICAL PHARMACOLOGY SECTION

Clinical Pharmacology

DRUG & OR LABORATORY TEST INTERACTIONS SECTION

Drug-Laboratory Interactions

PREGNANCY SECTION

pregnancy

NONTERATOGENIC EFFECTS SECTION

Non Terotogenic effects

LABOR & DELIVERY SECTION

labor and deliver

OVERDOSAGE SECTION

Overdosage

DOSAGE & ADMINISTRATION SECTION

Dosage and Administration

Adults and children

Infants and newborns

HOW SUPPLIED SECTION

how supplied

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Carcinogenesis

NURSING MOTHERS SECTION

Nursing Mothers

PEDIATRIC USE SECTION

Pediatric Use

ADVERSE REACTIONS SECTION

Adverse Reactions

INFORMATION FOR PATIENTS SECTION

Information for patients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

primary package label-bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

primary package label-carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Diazoxide Oral Solution
Diazoxide Oral Suspension
METHYLPARABEN
MAGNESIUM ALUMINUM SILICATE
SODIUM BENZOATE
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%)
PROPYLENE OXIDE
SORBITOL SOLUTION 70%
ALCOHOL
DIAZOXIDE
PROPYLENE GLYCOL, (R)-
HYDROCHLORIC ACID
PROPYLPARABEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80432-057	80432-057-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
METHYLPARABEN	A2I8C7HI9T	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%)	99H65D77XY	IACT
PROPYLENE OXIDE	Y4Y7NYD4BK	IACT
SORBITOL SOLUTION 70%	8KW3E207O2	IACT
ALCOHOL	3K9958V90M	IACT
DIAZOXIDE	O5CB12L4FN	ACTIB
PROPYLENE GLYCOL, (R)-	602HN5L69H	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211050-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211050-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211050-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211050-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211050-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211050-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211050-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211050-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211050-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211050-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211050-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211050-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211050-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211050-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211050-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211050-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211050-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211050-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211050-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211050-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211050-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211050-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211050-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211050-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211050-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211050-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211050-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211050-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211050-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211050-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211050-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211050-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211050-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211050-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211050-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211050-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211050-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211050-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211050-001	AB	1	`a50c72e98297…`

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…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f1863e5d-f2b6-2e47-e053-2a95a90af475			f1863e5d-f2b5-2e47-e053-2a95a90af475	2023-01-05	Warnings, Adverse reactions	Exact identifier spl id: f1863e5d-f2b6-2e47-e053-2a95a90af475 spl set id: f1863e5d-f2b5-2e47-e053-2a95a90af475

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.