NDC 51754-0104

Acetylcysteine

Acetylcysteine Injection

Acetylcysteine is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Exela Pharma Sciences, Llc. The primary component is Acetylcysteine.

Product ID51754-0104_1ec6f467-e66b-406a-ba60-bd4c5ce8fbaf
NDC51754-0104
Product TypeHuman Prescription Drug
Proprietary NameAcetylcysteine
Generic NameAcetylcysteine Injection
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2021-07-16
Marketing CategoryANDA /
Application NumberANDA204797
Labeler NameExela Pharma Sciences, 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 Through2022-12-31

Packaging

NDC 51754-0104-7

4 VIAL in 1 CARTON (51754-0104-7) > 30 mL in 1 VIAL
Marketing Start Date2021-07-16
NDC Exclude FlagN
Sample Package?N

Drug Details

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

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

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