Acetylcysteine is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Acetylcysteine.
Product ID | 63323-963_2d292664-30db-4cb4-8e38-21b5d684c635 |
NDC | 63323-963 |
Product Type | Human Prescription Drug |
Proprietary Name | Acetylcysteine |
Generic Name | Acetylcysteine |
Dosage Form | Injection, Solution |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2012-11-09 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA200644 |
Labeler Name | Fresenius Kabi USA, LLC |
Substance Name | ACETYLCYSTEINE |
Active Ingredient Strength | 200 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 | 2012-11-09 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA200644 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2012-11-09 |
Marketing Category | ANDA |
Application Number | ANDA200644 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2012-11-09 |
Marketing Category | ANDA |
Application Number | ANDA200644 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2012-11-09 |
Marketing Category | ANDA |
Application Number | ANDA200644 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2018-05-08 |
Ingredient | Strength |
---|---|
ACETYLCYSTEINE | 200 mg/mL |
SPL SET ID: | d990ef51-ced2-4359-b99b-092334d2dc9b |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
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 |