Label: DIAZOXIDE ORAL SOLUTION- diazoxide oral suspension suspension
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- NDC Code(s): 80432-057-06
- Packager: TriRx Huntsville Pharmaceutical Services LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 5, 2023
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- ANIMAL PHARMACOLOGY & OR TOXICOLOGY
- DESCRIPTION
- INDICATIONS & USAGE
- CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- LABORATORY TESTS
- DRUG INTERACTIONS
- CLINICAL PHARMACOLOGY
- DRUG & OR LABORATORY TEST INTERACTIONS
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- OVERDOSAGE
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- HOW SUPPLIED
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INGREDIENTS AND APPEARANCE
DIAZOXIDE ORAL SOLUTION
diazoxide oral suspension suspensionProduct 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)
