Proglycem
PROGLYCEM brand of diazoxide Capsules Suspension, USP
Approved
Approval ID
b16c7832-2fd9-49af-b923-1dc0d91fd6e2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 29, 2023
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
diazoxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0575-6200
Application NumberNDA017453
Product Classification
M
Marketing Category
C73594
G
Generic Name
diazoxide
Product Specifications
Route of AdministrationORAL
Effective DateMarch 29, 2023
FDA Product Classification
INGREDIENTS (13)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
DIAZOXIDEActive
Quantity: 50 mg in 1 mL
Code: O5CB12L4FN
Classification: ACTIB
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT