ACETYLCYSTEINE is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Cadila Healthcare Limited. The primary component is Acetylcysteine.
Product ID | 70771-1412_5237b85b-a643-42b8-83af-1def8f2449db |
NDC | 70771-1412 |
Product Type | Human Prescription Drug |
Proprietary Name | ACETYLCYSTEINE |
Generic Name | Acetylcysteine |
Dosage Form | Injection, Solution |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2019-01-17 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA208166 |
Labeler Name | Cadila Healthcare Limited |
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 | 2021-12-31 |
Marketing Start Date | 2019-01-17 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA208166 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-01-17 |
Marketing Category | ANDA |
Application Number | ANDA208166 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2019-01-17 |
Ingredient | Strength |
---|---|
ACETYLCYSTEINE | 200 mg/mL |
SPL SET ID: | c09faafd-af53-4fed-ae87-d16494758945 |
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 |