NDC 66220-207

ACETADOTE

Acetylcysteine

ACETADOTE is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Cumberland Pharmaceutical. The primary component is Acetylcysteine.

Product ID66220-207_084c6cf6-84dc-41ee-b1f0-c7411c53a4e6
NDC66220-207
Product TypeHuman Prescription Drug
Proprietary NameACETADOTE
Generic NameAcetylcysteine
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2004-01-23
Marketing CategoryNDA / NDA
Application NumberNDA021539
Labeler NameCumberland Pharmaceutical
Substance NameACETYLCYSTEINE
Active Ingredient Strength200 mg/mL
Pharm ClassesAntidote [EPC],
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 66220-207-30

4 VIAL in 1 CARTON (66220-207-30) > 30 mL in 1 VIAL
Marketing Start Date2004-01-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66220-207-30 [66220020730]

ACETADOTE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-01-23

Drug Details

Active Ingredients

IngredientStrength
ACETYLCYSTEINE200 mg/mL

OpenFDA Data

SPL SET ID:472f158a-5ab9-4308-8e49-1116e6ea3d39
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 582119
  • 465377

    • Pharmacological Class

    • Antidote [EPC]
    • Antidote for Acetaminophen Overdose [EPC]
    • Decreased Respiratory Secretion Viscosity [PE]
    • Increased Glutathione Concentration [PE]
    • Mucolytic [EPC]
    • Reduction Activity [MoA]

    NDC Crossover Matching brand name "ACETADOTE" or generic name "Acetylcysteine"

    NDCBrand NameGeneric Name
    66220-207ACETADOTEACETADOTE
    0409-3307AcetylcysteineACETYLCYSTEINE
    0409-3308AcetylcysteineACETYLCYSTEINE
    0517-7504Acetylcysteineacetylcysteine
    0517-7510Acetylcysteineacetylcysteine
    0517-7604Acetylcysteineacetylcysteine
    0517-7610Acetylcysteineacetylcysteine
    0517-7630Acetylcysteineacetylcysteine
    0574-0805acetylcysteineAcetylcysteine
    0574-0815Acetylcysteineacetylcysteine
    14445-412ACETYLCYSTEINEACETYLCYSTEINE
    17478-660AcetylcysteineAcetylcysteine
    25021-812Acetylcysteineacetylcysteine
    55150-259AcetylcysteineAcetylcysteine
    55154-5730AcetylcysteineAcetylcysteine
    55154-5731AcetylcysteineAcetylcysteine
    24338-700Cetylevacetylcysteine
    24338-707Cetylevacetylcysteine
    24338-725Cetylevacetylcysteine

    Trademark Results [ACETADOTE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ACETADOTE
    ACETADOTE
    76255015 2780113 Live/Registered
    Cumberland Pharmaceuticals Inc.
    2001-05-10
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.