NDC 50383-901

hydrocortisone and acetic acid

Hydrocortisone And Acetic Acid

hydrocortisone and acetic acid is a Auricular (otic) Solution in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Acetic Acid; Hydrocortisone.

Product ID50383-901_0ad314b3-4aaa-4c5f-8d26-9949c780d9e8
NDC50383-901
Product TypeHuman Prescription Drug
Proprietary Namehydrocortisone and acetic acid
Generic NameHydrocortisone And Acetic Acid
Dosage FormSolution
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2009-06-04
Marketing CategoryNDA / NDA
Application NumberNDA012770
Labeler NameHi-Tech Pharmacal Co., Inc.
Substance NameACETIC ACID; HYDROCORTISONE
Active Ingredient Strength21 mg/mL; mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50383-901-10

1 BOTTLE, DROPPER in 1 CARTON (50383-901-10) > 10 mL in 1 BOTTLE, DROPPER
Marketing Start Date2009-06-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-901-10 [50383090110]

hydrocortisone and acetic acid SOLUTION
Marketing CategoryNDA
Application NumberNDA012770
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-06-04

Drug Details

Active Ingredients

IngredientStrength
ACETIC ACID20.75 mg/mL

OpenFDA Data

SPL SET ID:ffd1edc1-2f40-4b0a-a53a-9fb53b8d3184
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313786
  • Pharmacological Class

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

    Medicade Reported Pricing

    50383090110 HYDROCORTISON-ACETIC ACID SOLN

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "hydrocortisone and acetic acid" or generic name "Hydrocortisone And Acetic Acid"

    NDCBrand NameGeneric Name
    50383-901hydrocortisone and acetic acidhydrocortisone and acetic acid
    51672-3007Hydrocortisone and Acetic AcidHydrocortisone and Acetic Acid
    0095-0201VoSoL HChydrocortisone and acetic acid

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