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

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Diazoxide Oral Suspension, USP

animal Pharmacology/Toxicology

Description

Indications and Usage

Contraindications

Warnings

Precautions

precautions 2

Laboratory Tests

Drug Interactions

Clinical Pharmacology

Drug-Laboratory Interactions

pregnancy

Non Terotogenic effects

labor and deliver

Overdosage

Dosage and Administration

Adults and children

Infants and newborns

how supplied

Carcinogenesis

Nursing Mothers

Pediatric Use

Adverse Reactions

Information for patients

primary package label-bottle

primary package label-carton

DIAZOXIDE ORAL SOLUTION 
diazoxide oral suspension suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80432-057
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIAZOXIDE (UNII: O5CB12L4FN) (DIAZOXIDE - UNII:O5CB12L4FN) DIAZOXIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80432-057-061 in 1 CARTON01/06/2023
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21105001/06/2023
Labeler - TriRx Huntsville Pharmaceutical Services LLC (117090286)
Establishment
NameAddressID/FEIBusiness Operations
TriRx Huntsville Pharmaceutical Services, LLC117090286manufacture(80432-057)

Revised: 1/2023
Document Id: f1863e5d-f2b6-2e47-e053-2a95a90af475
Set id: f1863e5d-f2b5-2e47-e053-2a95a90af475
Version: 1
Effective Time: 20230105
 
TriRx Huntsville Pharmaceutical Services LLC