Prednisone
PredniSONE Tablets, USP1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
Approved
Approval ID
10fe5a3b-84dc-4600-87c2-b80c97ce18cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 19, 2022
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 5
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 Code0603-5335
Application NumberANDA040584
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2022
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PREDNISONEActive
Quantity: 1 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
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 Code0603-5338
Application NumberANDA040256
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2022
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PREDNISONEActive
Quantity: 10 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Prednisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0603-5339
Application NumberANDA040392
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2022
FDA Product Classification
INGREDIENTS (6)
PREDNISONEActive
Quantity: 20 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Prednisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0603-5336
Application NumberANDA040581
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2022
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PREDNISONEActive
Quantity: 2.5 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Prednisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0603-5337
Application NumberANDA040256
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2022
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PREDNISONEActive
Quantity: 5 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT