Hydrocortisone
Approved
Approval ID
5bb45257-cf4e-4760-a1eb-37f27862e806
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 14, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5893
Application NumberANDA089074
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocortisone
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 14, 2011
FDA Product Classification
INGREDIENTS (17)
CARBOMER HOMOPOLYMER TYPE CInactive
Code: 4Q93RCW27E
Classification: IACT
DEHYDROACETIC ACIDInactive
Code: 2KAG279R6R
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
MYRISTYL LACTATEInactive
Code: 1D822OC34X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYOXYL 100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
SODIUM PYRROLIDONE CARBOXYLATEInactive
Code: 469OTG57A2
Classification: IACT
HYDROCORTISONEActive
Quantity: 25 mg in 1 mL
Code: WI4X0X7BPJ
Classification: ACTIB
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
DMDM HYDANTOINInactive
Code: BYR0546TOW
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
MYRISTYL ALCOHOLInactive
Code: V42034O9PU
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT