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NDC 72611-0860-04 ACETYLCYSTEINE 200 mg/mL Details
ACETYLCYSTEINE 200 mg/mL
ACETYLCYSTEINE is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Almaject, Inc.. The primary component is ACETYLCYSTEINE.
Product Information
| NDC | 72611-0860 |
|---|---|
| Product ID | 72611-860_0c3a3ef5-d364-8311-9d9e-f0097acdb82e |
| 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 |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/mL |
| Substance Name | ACETYLCYSTEINE |
| Labeler Name | Almaject, 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 | ANDA215620 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 72611-0860-04 (72611086004)
| NDC Package Code | 72611-860-04 |
|---|---|
| Billing NDC | 72611086004 |
| Package | 4 VIAL, SINGLE-DOSE in 1 CARTON (72611-860-04) / 30 mL in 1 VIAL, SINGLE-DOSE (72611-860-01) |
| Marketing Start Date | 2022-10-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |