Acetylcysteine is a Oral; Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Acetylcysteine.
| Product ID | 63323-691_05c9a4dd-4070-4725-8ee8-3c9484faf96e |
| NDC | 63323-691 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Acetylcysteine |
| Generic Name | Acetylcysteine |
| Dosage Form | Solution |
| Route of Administration | ORAL; RESPIRATORY (INHALATION) |
| Marketing Start Date | 2014-03-31 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA204674 |
| Labeler Name | Fresenius Kabi USA, LLC |
| Substance Name | ACETYLCYSTEINE |
| Active Ingredient Strength | 100 mg/mL |
| Pharm Classes | Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2014-03-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA204674 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-03-31 |
| Ingredient | Strength |
|---|---|
| ACETYLCYSTEINE | 100 mg/mL |
| SPL SET ID: | 75b48fab-cef6-465c-a1e0-d085b3988bc4 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0409-3307 | Acetylcysteine | ACETYLCYSTEINE |
| 0409-3308 | Acetylcysteine | ACETYLCYSTEINE |
| 0517-7504 | Acetylcysteine | acetylcysteine |
| 0517-7510 | Acetylcysteine | acetylcysteine |
| 0517-7604 | Acetylcysteine | acetylcysteine |
| 0517-7610 | Acetylcysteine | acetylcysteine |
| 0517-7630 | Acetylcysteine | acetylcysteine |
| 0574-0805 | acetylcysteine | Acetylcysteine |
| 0574-0815 | Acetylcysteine | acetylcysteine |
| 14445-412 | ACETYLCYSTEINE | ACETYLCYSTEINE |
| 17478-660 | Acetylcysteine | Acetylcysteine |
| 25021-812 | Acetylcysteine | acetylcysteine |
| 51754-0104 | Acetylcysteine | Acetylcysteine Injection |
| 55150-259 | Acetylcysteine | Acetylcysteine |
| 55154-5730 | Acetylcysteine | Acetylcysteine |
| 70710-1015 | ACETYLCYSTEINE | ACETYLCYSTEINE |
| 70771-1412 | ACETYLCYSTEINE | ACETYLCYSTEINE |
| 55154-5731 | Acetylcysteine | Acetylcysteine |
| 63323-690 | Acetylcysteine | Acetylcysteine |
| 63323-693 | Acetylcysteine | Acetylcysteine |
| 63323-694 | Acetylcysteine | Acetylcysteine |
| 63323-963 | Acetylcysteine | Acetylcysteine |
| 63323-692 | Acetylcysteine | Acetylcysteine |
| 63323-691 | Acetylcysteine | Acetylcysteine |
| 63323-695 | Acetylcysteine | Acetylcysteine |
| 24338-700 | Cetylev | acetylcysteine |
| 24338-707 | Cetylev | acetylcysteine |
| 24338-725 | Cetylev | acetylcysteine |