NDC 43749-250

Maximum Strength Hydrocortisone

Hydrocortisone Ointment

Maximum Strength Hydrocortisone is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Unipack, Inc.. The primary component is Hydrocortisone.

Product ID43749-250_0c99413c-996f-4a8a-b1a1-edf841a1388b
NDC43749-250
Product TypeHuman Otc Drug
Proprietary NameMaximum Strength Hydrocortisone
Generic NameHydrocortisone Ointment
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2018-02-03
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameUnipack, Inc.
Substance NameHYDROCORTISONE
Active Ingredient Strength1 g/100g
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 43749-250-01

1 TUBE in 1 CARTON (43749-250-01) > 28 g in 1 TUBE (43749-250-03)
Marketing Start Date2018-02-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43749-250-03 [43749025003]

Maximum Strength Hydrocortisone OINTMENT
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-02-03

NDC 43749-250-01 [43749025001]

Maximum Strength Hydrocortisone OINTMENT
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-02-03

Drug Details

Active Ingredients

IngredientStrength
HYDROCORTISONE1.02 g/100g

OpenFDA Data

SPL SET ID:f4d62ccb-4add-44ed-9798-2c37c739fa08
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 203105
  • UPC Code
  • 0351393005500
  • NDC Crossover Matching brand name "Maximum Strength Hydrocortisone" or generic name "Hydrocortisone Ointment"

    NDCBrand NameGeneric Name
    0363-0230Maximum Strength HydrocortisoneHydrocortisone Ointment
    24286-1560Maximum Strength HydrocortisoneHYDROCORTISONE
    43749-250Maximum Strength HydrocortisoneHydrocortisone Ointment
    69842-259Maximum Strength CortisoneHydrocortisone Ointment

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