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NDC 70710-1015-08 ACETYLCYSTEINE 200 mg/mL Details
ACETYLCYSTEINE 200 mg/mL
ACETYLCYSTEINE is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is ACETYLCYSTEINE.
Product Information
| NDC | 70710-1015 |
|---|---|
| Product ID | 70710-1015_cc19bb7d-8241-4ece-8fce-99c6029547c8 |
| 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 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/mL |
| Substance Name | ACETYLCYSTEINE |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| 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 | ANDA208166 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70710-1015-08 (70710101508)
| NDC Package Code | 70710-1015-8 |
|---|---|
| Billing NDC | 70710101508 |
| Package | 4 VIAL in 1 CARTON (70710-1015-8) / 30 mL in 1 VIAL (70710-1015-1) |
| Marketing Start Date | 2019-01-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |