Diazoxide Oral Suspension, USP

Diazoxide Oral Solution by

Drug Labeling and Warnings

Diazoxide Oral Solution by is a Prescription medication manufactured, distributed, or labeled by TriRx Huntsville Pharmaceutical Services LLC, TriRx Huntsville Pharmaceutical Services, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIAZOXIDE ORAL SOLUTION- diazoxide oral suspension suspension 
TriRx Huntsville Pharmaceutical Services LLC

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Diazoxide Oral Suspension, USP

DIAZOXIDE ORAL SOLUTION 
diazoxide oral suspension suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 80432-057
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIAZOXIDE (UNII: O5CB12L4FN) (DIAZOXIDE - UNII:O5CB12L4FN)	DIAZOXIDE	50 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80432-057-06	1 in 1 CARTON	01/06/2023
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211050	01/06/2023

Labeler - TriRx Huntsville Pharmaceutical Services LLC (117090286)

Establishment
Name	Address	ID/FEI	Business Operations
TriRx Huntsville Pharmaceutical Services, LLC		117090286	manufacture(80432-057)

Revised: 1/2023

Document Id: f1863e5d-f2b6-2e47-e053-2a95a90af475

34391-3

Set id: f1863e5d-f2b5-2e47-e053-2a95a90af475

Version: 1

Effective Time: 20230105

 

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