Prednisone
PredniSONE Tablets, USP Rx only
Approved
Approval ID
bcc8c648-fc70-44e8-9acc-cdf893097a38
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
Products 2
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 Code53002-3090
Application NumberANDA040362
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2017
FDA Product Classification
INGREDIENTS (6)
PREDNISONEActive
Quantity: 10 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
Starch, PotatoInactive
Code: 8I089SAH3T
Classification: IACT
Lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Prednisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53002-3250
Application NumberANDA040362
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2017
FDA Product Classification
INGREDIENTS (8)
PREDNISONEActive
Quantity: 20 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
Lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
Starch, PotatoInactive
Code: 8I089SAH3T
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
Fd&c Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT