PredniSONE
PredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE ™ Oral Solution (Concentrate)
Approved
Approval ID
9a76c658-6658-47a7-8f8d-b3994aef8585
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2022
Manufacturers
FDA
Cardinal Health 107, LLC
DUNS: 118546603
Products 4
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 Code55154-4946
Application NumberANDA087342
Product Classification
M
Marketing Category
C73584
G
Generic Name
PredniSONE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2021
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PREDNISONEActive
Quantity: 20 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PredniSONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55154-4950
Application NumberANDA084283
Product Classification
M
Marketing Category
C73584
G
Generic Name
PredniSONE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2021
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PREDNISONEActive
Quantity: 50 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PredniSONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55154-4938
Application NumberANDA080352
Product Classification
M
Marketing Category
C73584
G
Generic Name
PredniSONE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2021
FDA Product Classification
INGREDIENTS (7)
PREDNISONEActive
Quantity: 5 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PredniSONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55154-4949
Application NumberANDA084122
Product Classification
M
Marketing Category
C73584
G
Generic Name
PredniSONE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2021
FDA Product Classification
INGREDIENTS (6)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PREDNISONEActive
Quantity: 10 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT