NDC 50383-889

Acetic Acid

Acetic Acid

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.

Product ID50383-889_1b59e902-2b6a-4b5f-8ffe-2c17522e758f
NDC50383-889
Product TypeHuman Prescription Drug
Proprietary NameAcetic Acid
Generic NameAcetic Acid
Dosage FormSolution
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2010-01-22
Marketing CategoryNDA / NDA
Application NumberNDA012179
Labeler NameHi-Tech Pharmacal Co., Inc.
Substance NameACETIC ACID
Active Ingredient Strength21 mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50383-889-15

1 BOTTLE in 1 BOX (50383-889-15) > 15 mL in 1 BOTTLE
Marketing Start Date2010-01-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-889-15 [50383088915]

Acetic Acid SOLUTION
Marketing CategoryNDA
Application NumberNDA012179
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-01-22

Drug Details

Active Ingredients

IngredientStrength
ACETIC ACID20.65 mg/mL

OpenFDA Data

SPL SET ID:c53fc11e-b177-446e-839d-391e1b2eacff
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197305
  • Medicade Reported Pricing

    50383088915 ACETIC ACID 2% EAR SOLUTION

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Acetic Acid" or generic name "Acetic Acid"

    NDCBrand NameGeneric Name
    0264-2304Acetic AcidAcetic Acid
    0338-0656Acetic AcidAcetic Acid
    0409-6143Acetic AcidAcetic Acid
    0990-6143Acetic AcidAcetic Acid
    21695-222acetic acidacetic acid
    50090-0351acetic acidAcetic Acid
    50090-3020ACETIC ACIDAcetic Acid
    50383-889Acetic AcidAcetic Acid
    50436-4600Acetic AcidAcetic Acid
    52817-816Acetic AcidAcetic Acid
    55045-1243acetic acidacetic acid
    55700-424acetic acidacetic acid
    60432-741ACETIC ACIDAcetic Acid
    64980-424Acetic AcidAcetic Acid
    68071-1739Acetic AcidAcetic Acid
    68071-3304Acetic AcidACETIC ACID
    68788-7231Acetic AcidAcetic Acid
    0220-0030Aceticum acidumACETIC ACID
    68428-175Aceticum AcidumACETIC ACID
    71919-006Aceticum acidumACETIC ACID
    64117-202DYSPEPSIA FATIGUEACETIC ACID
    81463-0002New CleanFlexacetic acid

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.