Hydrocortisone
Hydrocortisone Tablets, USP
Approved
Approval ID
5b707a9f-32b6-42f3-beb6-111df98dfde5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-186
Application NumberANDA085070
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocortisone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2023
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
HYDROCORTISONEActive
Quantity: 20 mg in 1 1
Code: WI4X0X7BPJ
Classification: ACTIB