Hydrocortisone

Product NDC
53002-8350
11-digit product format
530028350
Labeler code
53002
Product ID
53002-8350_d13c5618-cd91-45b4-8c37-9763a01e772d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA080692
Marketing category
ANDA
Marketing start
1975-04-16
Marketing end
0000-00-00
Substance
HYDROCORTISONE
Active strength
10 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
WI4X0X7BPJHYDROCORTISONE50-23-7HYDROCORTISONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-8350-15300283500130 g in 1 TUBE (53002-8350-1) 30 g2022-06-010000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HYDROCORTISONE OINTMENT USP, 1%RPK Pharmaceuticals, Inc.2022-03-30HUMAN PRESCRIPTION DRUG LABEL1