NDC 70710-1015

ACETYLCYSTEINE

Acetylcysteine

ACETYLCYSTEINE is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals Usa Inc.. The primary component is Acetylcysteine.

Product ID70710-1015_9f59a19f-ffa1-4ecf-98df-1e0f3de37ed1
NDC70710-1015
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 NameZydus Pharmaceuticals USA 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 Through2023-12-31

Packaging

NDC 70710-1015-8

4 VIAL in 1 CARTON (70710-1015-8) > 30 mL in 1 VIAL (70710-1015-1)
Marketing Start Date2019-01-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70710-1015-1 [70710101501]

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

NDC 70710-1015-8 [70710101508]

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:c35cd2d4-6a28-4ba9-8cca-d6557fe50438
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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