Hydrocortisone
Hydrocortisone Cream USP, 1%, 2.5%
Approved
Approval ID
a84830ad-73dc-4a2e-b987-0a1103526535
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2023
Manufacturers
FDA
Crown Laboratories
DUNS: 079035945
Products 2
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 Code0316-0193
Application NumberANDA080706
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocortisone
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 24, 2023
FDA Product Classification
INGREDIENTS (9)
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CETYL PALMITATEInactive
Code: 5ZA2S6B08X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
HYDROCORTISONEActive
Quantity: 25 mg in 1 g
Code: WI4X0X7BPJ
Classification: ACTIB
Hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0316-0186
Application NumberANDA080706
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocortisone
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 24, 2023
FDA Product Classification
INGREDIENTS (9)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
HYDROCORTISONEActive
Quantity: 10 mg in 1 g
Code: WI4X0X7BPJ
Classification: ACTIB
CETYL PALMITATEInactive
Code: 5ZA2S6B08X
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT