NDC 63323-963

Acetylcysteine

Acetylcysteine

Acetylcysteine is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Acetylcysteine.

Product ID63323-963_2d292664-30db-4cb4-8e38-21b5d684c635
NDC63323-963
Product TypeHuman Prescription Drug
Proprietary NameAcetylcysteine
Generic NameAcetylcysteine
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2012-11-09
Marketing CategoryANDA / ANDA
Application NumberANDA200644
Labeler NameFresenius Kabi USA, LLC
Substance NameACETYLCYSTEINE
Active Ingredient Strength200 mg/mL
Pharm ClassesAntidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63323-963-44

4 VIAL, SINGLE-DOSE in 1 CARTON (63323-963-44) > 30 mL in 1 VIAL, SINGLE-DOSE (63323-963-41)
Marketing Start Date2012-11-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-963-30 [63323096330]

Acetylcysteine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA200644
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-11-09

NDC 63323-963-41 [63323096341]

Acetylcysteine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA200644
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-11-09

NDC 63323-963-44 [63323096344]

Acetylcysteine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA200644
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-11-09

NDC 63323-963-21 [63323096321]

Acetylcysteine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA200644
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-05-08

Drug Details

Active Ingredients

IngredientStrength
ACETYLCYSTEINE200 mg/mL

OpenFDA Data

SPL SET ID:d990ef51-ced2-4359-b99b-092334d2dc9b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 465377
  • Pharmacological Class

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

    Medicade Reported Pricing

    63323096330 ACETYLCYSTEINE 6 GRAM/30 ML VL

    Pricing Unit: ML | Drug Type:

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

    NDCBrand NameGeneric Name
    0409-3307AcetylcysteineACETYLCYSTEINE
    0409-3308AcetylcysteineACETYLCYSTEINE
    0517-7504Acetylcysteineacetylcysteine
    0517-7510Acetylcysteineacetylcysteine
    0517-7604Acetylcysteineacetylcysteine
    0517-7610Acetylcysteineacetylcysteine
    0517-7630Acetylcysteineacetylcysteine
    0574-0805acetylcysteineAcetylcysteine
    0574-0815Acetylcysteineacetylcysteine
    14445-412ACETYLCYSTEINEACETYLCYSTEINE
    17478-660AcetylcysteineAcetylcysteine
    25021-812Acetylcysteineacetylcysteine
    51754-0104AcetylcysteineAcetylcysteine Injection
    55150-259AcetylcysteineAcetylcysteine
    55154-5730AcetylcysteineAcetylcysteine
    70710-1015ACETYLCYSTEINEACETYLCYSTEINE
    70771-1412ACETYLCYSTEINEACETYLCYSTEINE
    55154-5731AcetylcysteineAcetylcysteine
    63323-690AcetylcysteineAcetylcysteine
    63323-693AcetylcysteineAcetylcysteine
    63323-694AcetylcysteineAcetylcysteine
    63323-963AcetylcysteineAcetylcysteine
    63323-692AcetylcysteineAcetylcysteine
    63323-691AcetylcysteineAcetylcysteine
    63323-695AcetylcysteineAcetylcysteine
    24338-700Cetylevacetylcysteine
    24338-707Cetylevacetylcysteine
    24338-725Cetylevacetylcysteine

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