Hydrocortisone

Product NDC
63629-8817
11-digit product format
636298817
Labeler code
63629
Product ID
63629-8817_51c786a9-6130-44e1-891f-dc16ac377606
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA081203
Marketing category
ANDA
Marketing start
1993-05-28
Substance
HYDROCORTISONE
Active strength
25 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
63629-8817_51c786a9-6130-44e1-891f-dc16ac377606
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Hydrocortisone
Generic name
Hydrocortisone
Dosage form
OINTMENT
Route
TOPICAL
Marketing start
1993-05-28
Marketing category
ANDA
Application number
ANDA081203
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA]; Corticosteroid [EPC]
Listing expiration
2026-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
HYDROCORTISONE25 mg/g

openFDA Harmonized Identifiers

FieldValues
UniiWI4X0X7BPJ
Rxcui103401
Spl Set Idc4013d86-e134-43c3-ad75-7e680a9d2ae7
Manufacturer NameBryant Ranch Prepack

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
WI4X0X7BPJHYDROCORTISONE50-23-7HYDROCORTISONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8817-16362988170129 g in 1 TUBE (63629-8817-1) 29 g2021-09-100000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%Bryant Ranch Prepack2024-01-11HUMAN PRESCRIPTION DRUG LABEL102