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NDC 51754-0105-08 Acetylcysteine 200 mg/mL Details
Acetylcysteine 200 mg/mL
Acetylcysteine is a ORAL; RESPIRATORY (INHALATION) SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Exela Pharma Sciences, LLC. The primary component is ACETYLCYSTEINE.
MedlinePlus Drug Summary
Acetylcysteine inhalation is used along with other treatments to relieve chest congestion due to thick or abnormal mucous secretions in people with lung conditions including asthma, emphysema, bronchitis and cystic fibrosis (an inborn disease that causes problems with breathing, digestion, and reproduction). Acetylcysteine is in a class of medications called mucolytic agents. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 51754-0105-08Last Updated: 04/21/2024
MedLinePlus Full Drug Details: Acetylcysteine Oral Inhalation
Product Information
| NDC | 51754-0105 |
|---|---|
| Product ID | 51754-0105_5cc9bfdb-0160-4a8c-a85f-d1fe0f95c8c3 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Acetylcysteine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetylcysteine Solution |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL; RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/mL |
| Substance Name | ACETYLCYSTEINE |
| Labeler Name | Exela Pharma Sciences, LLC |
| Pharmaceutical Class | Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205643 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 51754-0105-08 (51754010508)
| NDC Package Code | 51754-0105-8 |
|---|---|
| Billing NDC | 51754010508 |
| Package | 3 VIAL in 1 CARTON (51754-0105-8) / 30 mL in 1 VIAL |
| Marketing Start Date | 2023-11-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |