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NDC 70436-0212-80 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 Slate Run Pharmaceuticals, LLC. The primary component is GADOBUTROL.
Product Information
| NDC | 70436-0212 |
|---|---|
| Product ID | 70436-212_099b1475-9a8e-2d9a-e063-6294a90a9f8b |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| 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 | Slate Run Pharmaceuticals, LLC |
| Pharmaceutical Class | Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA217480 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70436-0212-80 (70436021280)
| NDC Package Code | 70436-212-80 |
|---|---|
| Billing NDC | 70436021280 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (70436-212-80) / 7.5 mL in 1 VIAL, SINGLE-DOSE (70436-212-32) |
| Marketing Start Date | 2023-10-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |