Hydrocortisone (Page 2 of 2)

HOW SUPPLIED:

Product: 53002-8350

NDC: 53002-8350-1 30 g in a TUBE

Hydrocortisone 1% Ointment

Label Image
(click image for full-size original)
HYDROCORTISONE
hydrocortisone ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-8350(NDC:0168-0020)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
petrolatum
mineral oil
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53002-8350-1 30 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080692 04/16/1975
Labeler — RPK Pharmaceuticals, Inc. (147096275)
Establishment
Name Address ID/FEI Operations
RPK Pharmaceuticals, Inc. 147096275 RELABEL (53002-8350), REPACK (53002-8350)

Revised: 03/2022 RPK Pharmaceuticals, Inc.

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.