gadobutrol
- Product NDC
- 70436-213
- 11-digit product format
- 704360213
- Labeler code
- 70436
- Product ID
- 70436-213_3304f07e-e137-e806-e063-6394a90a8a4a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gadobutrol
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Slate Run Pharmaceuticals, LLC
- Application
- ANDA217480
- Marketing category
- ANDA
- Marketing start
- 2025-04-16
- Substance
- GADOBUTROL
- Active strength
- 604.72 mg/mL
- Pharmacologic classes
- Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- gadobutrol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GADOBUTROL | 604.72 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1BJ477IO2L |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70436-213-33 | gadobutrol | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 4 |
| 70436-213-82 | gadobutrol | 10 in 1 CARTON | INJECTION | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70436-213 | GADOBUTROL INJECTION [SLATE RUN PHARMACEUTICALS, LLC] | 4 | Current NDC, 2 package rows | 20250419_832e0ae1-4fe1-4dff-9978-c9200bcebb55.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70436-213-33 | 70436021333 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | Historical |
| 70436-213-82 | 70436021382 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-213-82) / 10 mL in 1 VIAL, SINGLE-DOSE (70436-213-33) | | 2025-04-16 | No | No | Current |