NDC 0517-7630

Acetylcysteine

Acetylcysteine

Acetylcysteine is a Respiratory (inhalation) Inhalant in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Acetylcysteine.

Product ID0517-7630_87d790b1-9137-4dce-b6fe-d87ae528bc51
NDC0517-7630
Product TypeHuman Prescription Drug
Proprietary NameAcetylcysteine
Generic NameAcetylcysteine
Dosage FormInhalant
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date1995-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA072547
Labeler NameAmerican Regent, Inc.
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 Through2020-12-31

Packaging

NDC 0517-7630-03

3 VIAL, GLASS in 1 BOX (0517-7630-03) > 30 mL in 1 VIAL, GLASS
Marketing Start Date1995-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0517-7630-03 [00517763003]

Acetylcysteine INHALANT
Marketing CategoryANDA
Application NumberANDA072547
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1995-10-01

Drug Details

Active Ingredients

IngredientStrength
ACETYLCYSTEINE200 mg/mL

OpenFDA Data

SPL SET ID:f56b4087-db48-4fd7-84ec-9c927962b805
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 307718
  • 307719
  • UPC Code
  • 0305177504253
  • 0305177630037
  • 0305177604250
  • 0305177510032
  • 0305177610039
  • 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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