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NDC 25021-0812-30 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 Sagent Pharmaceuticals. The primary component is ACETYLCYSTEINE.
Product Information
| NDC | 25021-0812 |
|---|---|
| Product ID | 25021-812_d2afdd40-ad6f-4a30-9700-084b13c11ba6 |
| Associated GPIs | 93000007002020 |
| 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 | Sagent Pharmaceuticals |
| 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 | ANDA091684 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 25021-0812-30 (25021081230)
| NDC Package Code | 25021-812-30 |
|---|---|
| Billing NDC | 25021081230 |
| Package | 4 VIAL in 1 CARTON (25021-812-30) / 30 mL in 1 VIAL |
| Marketing Start Date | 2018-04-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |