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NDC 70594-0111-02 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 Xellia Pharmaceuticals USA LLC. The primary component is ACETYLCYSTEINE.
Product Information
| NDC | 70594-0111 |
|---|---|
| Product ID | 70594-111_bfb03f99-1389-424a-a457-efbb23f198ee |
| Associated GPIs | |
| GCN Sequence Number | 024398 |
| GCN Sequence Number Description | acetylcysteine VIAL 200 MG/ML INTRAVEN |
| HIC3 | C8E |
| HIC3 Description | ANTIDOTES,MISCELLANEOUS |
| GCN | 04391 |
| HICL Sequence Number | 000189 |
| HICL Sequence Number Description | ACETYLCYSTEINE |
| Brand/Generic | Generic |
| 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 | Xellia Pharmaceuticals USA 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 | ANDA217182 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70594-0111-02 (70594011102)
| NDC Package Code | 70594-111-02 |
|---|---|
| Billing NDC | 70594011102 |
| Package | 4 VIAL in 1 CARTON (70594-111-02) / 30 mL in 1 VIAL (70594-111-01) |
| Marketing Start Date | 2023-06-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |