gadobutrol
- Product NDC
- 70436-216
- 11-digit product format
- 704360216
- Labeler code
- 70436
- Product ID
- 70436-216_3304ec39-b300-eb0a-e063-6394a90a1cd1
- 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 |
|---|
| 70436-216-36 | gadobutrol | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION | 30 | | 1 |
| 70436-216-51 | gadobutrol | 5 in 1 CARTON | INJECTION | 5 | | 1 |
| 70436-216-77 | gadobutrol | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION | 30 | | 1 |
| 70436-216-81 | gadobutrol | 5 in 1 CARTON | INJECTION | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70436-216 | GADOBUTROL INJECTION [SLATE RUN PHARMACEUTICALS, LLC] | 1 | Current NDC, 2 package rows | 20250419_4af6ee2b-d039-497f-a8f0-bdf948e5f54e.zip |
| 70436-216 | GADOBUTROL INJECTION [SLATE RUN PHARMACEUTICALS, LLC] | 1 | Current NDC, 2 package rows | 20250419_52fbda34-9974-4f9f-9749-6b17d0495b62.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70436-216-36 | 70436021636 | 30 mL in 1 VIAL, MULTI-DOSE | 30 ml | | | | Historical |
| 70436-216-51 | 70436021651 | 5 VIAL, MULTI-DOSE in 1 CARTON (70436-216-51) / 30 mL in 1 VIAL, MULTI-DOSE (70436-216-77) | | 2025-04-16 | No | No | Current |
| 70436-216-77 | 70436021677 | 30 mL in 1 VIAL, MULTI-DOSE | 30 ml | | | | Historical |
| 70436-216-81 | 70436021681 | 5 VIAL, MULTI-DOSE in 1 CARTON (70436-216-81) / 30 mL in 1 VIAL, MULTI-DOSE (70436-216-36) | | 2025-04-16 | No | No | Current |