Hydrocortisone Butyrate
Hydrocortisone Butyrate Ointment, 0.1% Hydrocortisone Butyrate Cream USP, 0.1% Hydrocortisone Butyrate Topical Solution, 0.1%
Approved
Approval ID
51176835-598d-4da7-8a00-6bd36f52aa82
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 6, 2021
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocortisone Butyrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4083
Application NumberANDA076842
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocortisone Butyrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 6, 2021
FDA Product Classification
INGREDIENTS (3)
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
high density polyethyleneInactive
Code: UG00KM4WR7
Classification: IACT
Hydrocortisone ButyrateActive
Quantity: 1 mg in 1 g
Code: 05RMF7YPWN
Classification: ACTIB
Hydrocortisone Butyrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4061
Application NumberANDA076364
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocortisone Butyrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 6, 2021
FDA Product Classification
INGREDIENTS (7)
Hydrocortisone ButyrateActive
Quantity: 1 mg in 1 mL
Code: 05RMF7YPWN
Classification: ACTIB
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
trisodium citrate dihydrateInactive
Code: B22547B95K
Classification: IACT
Hydrocortisone Butyrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4074
Application NumberANDA076654
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocortisone Butyrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 6, 2021
FDA Product Classification
INGREDIENTS (10)
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
light mineral oilInactive
Code: N6K5787QVP
Classification: IACT
Hydrocortisone ButyrateActive
Quantity: 1 mg in 1 g
Code: 05RMF7YPWN
Classification: ACTIB
ceteth-20Inactive
Code: I835H2IHHX
Classification: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1S
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
butylparabenInactive
Code: 3QPI1U3FV8
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
anhydrous trisodium citrateInactive
Code: RS7A450LGA
Classification: IACT