Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Crown Laboratories
079035945
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Crown Laboratories
Crown Laboratories
Crown Laboratories
079035945
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocortisone
Product Details
NDC Product Code
0316-0193Application Number
ANDA080706Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
October 24, 2023CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
CETYL PALMITATEInactive
Code: 5ZA2S6B08XClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SORBIC ACIDInactive
Code: X045WJ989BClass: IACT
HydrocortisoneActive
Code: WI4X0X7BPJClass: ACTIBQuantity: 25 mg in 1 g
Hydrocortisone
Product Details
NDC Product Code
0316-0186Application Number
ANDA080706Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
October 24, 2023WATERInactive
Code: 059QF0KO0RClass: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
HydrocortisoneActive
Code: WI4X0X7BPJClass: ACTIBQuantity: 10 mg in 1 g
CETYL PALMITATEInactive
Code: 5ZA2S6B08XClass: IACT
SORBIC ACIDInactive
Code: X045WJ989BClass: IACT