HYDROCORTISONE
Hydrocortisone Tablets, USP 5 mg, 10 mg and 20 mg Rx only
Approved
Approval ID
9fe627ad-4aba-4bd1-8590-6cc2d61674ba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2023
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1696
Application NumberANDA040646
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrocortisone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2023
FDA Product Classification
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROCORTISONEActive
Quantity: 5 mg in 1 1
Code: WI4X0X7BPJ
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1697
Application NumberANDA040646
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrocortisone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2023
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROCORTISONEActive
Quantity: 10 mg in 1 1
Code: WI4X0X7BPJ
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1700
Application NumberANDA040646
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrocortisone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2023
FDA Product Classification
INGREDIENTS (7)
HYDROCORTISONEActive
Quantity: 20 mg in 1 1
Code: WI4X0X7BPJ
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT