HYDROCORTISONE
Approved
Approval ID
4e16f4eb-5bd1-4143-9bf8-d852175a598a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
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 Code16590-990
Application NumberANDA083365
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCORTISONE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2011
FDA Product Classification
INGREDIENTS (6)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROCORTISONEActive
Quantity: 20 mg in 1 1
Code: WI4X0X7BPJ
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT