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NDC 66220-0207-30 ACETADOTE 200 mg/mL Details
ACETADOTE 200 mg/mL
ACETADOTE is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cumberland Pharmaceuticals Inc.. The primary component is ACETYLCYSTEINE.
Product Information
| NDC | 66220-0207 |
|---|---|
| Product ID | 66220-207_25a2135a-ff86-4f54-87ae-22f2020c4bbb |
| 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 | Brand |
| Proprietary Name | ACETADOTE |
| 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 | Cumberland Pharmaceuticals 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 | NDA |
| Application Number | NDA021539 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 66220-0207-30 (66220020730)
| NDC Package Code | 66220-207-30 |
|---|---|
| Billing NDC | 66220020730 |
| Package | 4 VIAL in 1 CARTON (66220-207-30) / 30 mL in 1 VIAL |
| Marketing Start Date | 2004-01-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |