Hydrocortisone
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%
Approved
Approval ID
0e606cee-da75-416d-81a3-b90faf9b8528
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 21, 2017
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
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 Code50436-2143
Application NumberANDA089414
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocortisone
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 10, 2014
FDA Product Classification
INGREDIENTS (12)
HYDROCORTISONEActive
Quantity: 25 mg in 1 g
Code: WI4X0X7BPJ
Classification: ACTIB
potassium sorbateInactive
Code: 1VPU26JZZ4
Classification: IACT
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
paraffinInactive
Code: I9O0E3H2ZE
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
glyceryl monostearateInactive
Code: 230OU9XXE4
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
isopropyl palmitateInactive
Code: 8CRQ2TH63M
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
sorbitan monostearateInactive
Code: NVZ4I0H58X
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
polyoxyl 40 stearateInactive
Code: 13A4J4NH9I
Classification: IACT