NDC 55154-5730

Acetylcysteine

Acetylcysteine

Acetylcysteine is a Oral; Respiratory (inhalation) Inhalant in the Human Prescription Drug category. It is labeled and distributed by Cardinal Health 107, Llc. The primary component is Acetylcysteine.

Product ID55154-5730_1bfcd79e-ea3d-44c5-90d2-02304b963d70
NDC55154-5730
Product TypeHuman Prescription Drug
Proprietary NameAcetylcysteine
Generic NameAcetylcysteine
Dosage FormInhalant
Route of AdministrationORAL; RESPIRATORY (INHALATION)
Marketing Start Date2011-05-06
Marketing CategoryANDA / ANDA
Application NumberANDA072489
Labeler NameCardinal Health 107, LLC
Substance NameACETYLCYSTEINE
Active Ingredient Strength100 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 55154-5730-5

5 VIAL in 1 BAG (55154-5730-5) > 4 mL in 1 VIAL
Marketing Start Date2011-05-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55154-5730-5 [55154573005]

Acetylcysteine INHALANT
Marketing CategoryANDA
Application NumberANDA072489
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-06

Drug Details

Active Ingredients

IngredientStrength
ACETYLCYSTEINE100 mg/mL

OpenFDA Data

SPL SET ID:c90fca12-12fb-4cf6-bd6f-83bc0d95df81
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 307718
  • 307719
  • UPC Code
  • 0055154573153
  • 0055154573054
  • 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 "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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