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NDC 65219-0289-65 Gadobutrol 604.72 mg/mL Details
Gadobutrol 604.72 mg/mL
Gadobutrol is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is GADOBUTROL.
Product Information
| NDC | 65219-0289 |
|---|---|
| Product ID | 65219-289_54027cd5-9739-4e3a-8485-ff2928426ebc |
| Associated GPIs | |
| GCN Sequence Number | 054612 |
| GCN Sequence Number Description | gadobutrol VIAL 1 MMOL/ML INTRAVEN |
| HIC3 | Z9D |
| HIC3 Description | DIAGNOSTIC PREPARATIONS,MISCELLANEOUS |
| GCN | 22586 |
| HICL Sequence Number | 021847 |
| HICL Sequence Number Description | GADOBUTROL |
| Brand/Generic | Generic |
| Proprietary Name | Gadobutrol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Gadobutrol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 604.72 |
| Active Ingredient Units | mg/mL |
| Substance Name | GADOBUTROL |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA216081 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65219-0289-65 (65219028965)
| NDC Package Code | 65219-289-65 |
|---|---|
| Billing NDC | 65219028965 |
| Package | 10 BOTTLE in 1 CARTON (65219-289-65) / 65 mL in 1 BOTTLE (65219-289-10) |
| Marketing Start Date | 2023-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |