NDC 72611-860

ACETYLCYSTEINE

Acetylcysteine

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

Product ID72611-860_c32fe773-7b1e-a499-c4ca-c6cee49da0c5
NDC72611-860
Product TypeHuman Prescription Drug
Proprietary NameACETYLCYSTEINE
Generic NameAcetylcysteine
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2022-10-17
Marketing CategoryANDA /
Application NumberANDA215620
Labeler NameAlmaject, 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 72611-860-04

4 VIAL, SINGLE-DOSE in 1 CARTON (72611-860-04) > 30 mL in 1 VIAL, SINGLE-DOSE (72611-860-01)
Marketing Start Date2022-10-24
NDC Exclude FlagN
Sample Package?N

Drug Details

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.