NDC 70771-1412

ACETYLCYSTEINE

Acetylcysteine

ACETYLCYSTEINE is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Cadila Healthcare Limited. The primary component is Acetylcysteine.

Product ID70771-1412_5237b85b-a643-42b8-83af-1def8f2449db
NDC70771-1412
Product TypeHuman Prescription Drug
Proprietary NameACETYLCYSTEINE
Generic NameAcetylcysteine
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-01-17
Marketing CategoryANDA / ANDA
Application NumberANDA208166
Labeler NameCadila Healthcare Limited
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 Through2021-12-31

Packaging

NDC 70771-1412-8

4 VIAL in 1 CARTON (70771-1412-8) > 30 mL in 1 VIAL (70771-1412-1)
Marketing Start Date2019-01-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1412-8 [70771141208]

ACETYLCYSTEINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA208166
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-17

NDC 70771-1412-1 [70771141201]

ACETYLCYSTEINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA208166
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-17

Drug Details

Active Ingredients

IngredientStrength
ACETYLCYSTEINE200 mg/mL

OpenFDA Data

SPL SET ID:c09faafd-af53-4fed-ae87-d16494758945
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]

    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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