NDC 14445-412

ACETYLCYSTEINE

Acetylcysteine

ACETYLCYSTEINE is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Indoco Remedies Limited. The primary component is Acetylcysteine.

Product ID14445-412_2b8da336-9b90-466e-9ac2-6f6cbb999f9f
NDC14445-412
Product TypeHuman Prescription Drug
Proprietary NameACETYLCYSTEINE
Generic NameAcetylcysteine
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2022-03-01
Marketing CategoryANDA /
Application NumberANDA215620
Labeler NameIndoco Remedies 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 Through2023-12-31

Packaging

NDC 14445-412-04

4 VIAL in 1 CARTON (14445-412-04) > 30 mL in 1 VIAL (14445-412-30)
Marketing Start Date2022-03-01
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
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