Gadobutrol
- Product NDC
- 65219-289
- 11-digit product format
- 652190289
- Labeler code
- 65219
- Product ID
- 65219-289_d546f4fe-ebb3-47cf-9222-563d15caa8b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gadobutrol
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA216081
- Marketing category
- ANDA
- Marketing start
- 2023-10-01
- 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 |
|---|
| 65219-289-10 | Gadobutrol | 65 mL in 1 BOTTLE | INJECTION | 65 | | 4 |
| 65219-289-65 | 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 |
|---|
| 65219-289 | GADOBUTROL INJECTION [FRESENIUS KABI USA, LLC] | 2 | Current NDC, 2 package rows | 20250119_c0dd1618-0bb3-4974-846b-e5afc2311ae6.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-289-10 | 65219028910 | 65 mL in 1 BOTTLE | 65 ml | | | | Historical |
| 65219-289-65 | 65219028965 | 10 BOTTLE in 1 CARTON (65219-289-65) / 65 mL in 1 BOTTLE (65219-289-10) | 10 bottle | 2023-10-01 | No | No | Current |