HYDROCORTISONE BUTYRATE

Manufacturing Establishments (1)

Labeler

Oceanside Pharmaceuticals

DUNS Number

005320536

NDC Product Code

68682-392

Application Number

NDA022076

Marketing Category

NDA authorized generic (C73605)

Route of Administration

TOPICAL

Effective Date

December 11, 2023

Ingredients

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

CETETH-20Inactive

Code: I835H2IHHXClass: IACT

CETOSTEARYL ALCOHOLInactive

Code: 2DMT128M1SClass: IACT

BUTYLATED HYDROXYTOLUENEInactive

Code: 1P9D0Z171KClass: IACT

BUTYLPARABENInactive

Code: 3QPI1U3FV8Class: IACT

LIGHT MINERAL OILInactive

Code: N6K5787QVPClass: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULRClass: IACT

PETROLATUMInactive

Code: 4T6H12BN9UClass: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SAFFLOWER OILInactive

Code: 65UEH262ISClass: IACT

Code: 05RMF7YPWNClass: ACTIBQuantity: 1 mg in 1 mL