MiCort HC

Product NDC

54766-835

11-digit product format

547660835

Labeler code

54766

Product ID

54766-835_8ca3626f-0fa8-962c-e053-2995a90a02a0

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

hydrocortisone acetate

Dosage form

CREAM

Route

TOPICAL

Labeler

Sebela Pharmaceuticals Inc.

Application

ANDA040396

Marketing category

ANDA

Marketing start

2016-09-13

Marketing end

2020-05-31

Substance

HYDROCORTISONE ACETATE

Active strength

25 mg/g

Pharmacologic classes

Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record