Deltasone
Deltasone Tablets USP
Approved
Approval ID
d0acd7fb-8401-424f-9acc-a74dcd9b14f6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2018
Manufacturers
FDA
Sonoma Pharmaceuticals, Inc.
DUNS: 081642964
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PredniSONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69668-220
Application NumberANDA087342
Product Classification
M
Marketing Category
C73584
G
Generic Name
PredniSONE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 2, 2018
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM GLYCOLATEInactive
Code: B75E535IMI
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PREDNISONEActive
Quantity: 20 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB