Hydrocortisone
TOPICAL CORTICOSTEROID
Approved
Approval ID
aa9dba84-eb38-4ec3-8555-87c948bf2384
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 10, 2020
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
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 Code0472-0321
Application NumberANDA087795
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocortisone
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 30, 2017
FDA Product Classification
INGREDIENTS (10)
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYDROCORTISONEActive
Quantity: 10 mg in 1 g
Code: WI4X0X7BPJ
Classification: ACTIB
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT