GADOTERIDOL
- Product NDC
- 70436-121
- 11-digit product format
- 704360121
- Labeler code
- 70436
- Product ID
- 70436-121_3f886711-cb41-3241-e063-6394a90a5bc7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GADOTERIDOL
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Slate Run Pharmaceuticals, LLC
- Application
- ANDA218749
- Marketing category
- ANDA
- Marketing start
- 2025-02-20
- Substance
- GADOTERIDOL
- Active strength
- 279.3 mg/mL
- Pharmacologic classes
- Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GADOTERIDOL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GADOTERIDOL | 279.3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0199MV609F |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70436-121-31 | GADOTERIDOL | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 5 | | 2 |
| 70436-121-31 | GADOTERIDOL | 5 in 1 CARTON | INJECTION | 5 | | 2 |
| 70436-121-33 | GADOTERIDOL | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 2 |
| 70436-121-33 | GADOTERIDOL | 5 in 1 CARTON | INJECTION | 5 | | 2 |
| 70436-121-34 | GADOTERIDOL | 15 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 15 | | 2 |
| 70436-121-34 | GADOTERIDOL | 5 in 1 CARTON | INJECTION | 5 | | 2 |
| 70436-121-35 | GADOTERIDOL | 5 in 1 CARTON | INJECTION | 5 | | 2 |
| 70436-121-35 | GADOTERIDOL | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 20 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70436-121 | GADOTERIDOL INJECTION [SLATE RUN PHARMACEUTICALS, LLC] | 1 | Current NDC, 8 package rows | 20250223_538a70e0-061c-40d2-8447-5b7a4e61a55f.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70436-121-31 | 70436012131 | 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-31) / 5 mL in 1 VIAL, SINGLE-DOSE | 2025-02-20 | No | No | Historical |
| 70436-121-33 | 70436012133 | 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-33) / 10 mL in 1 VIAL, SINGLE-DOSE | 2025-02-20 | No | No | Historical |
| 70436-121-34 | 70436012134 | 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-34) / 15 mL in 1 VIAL, SINGLE-DOSE | 2025-02-20 | No | No | Historical |
| 70436-121-35 | 70436012135 | 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-35) / 20 mL in 1 VIAL, SINGLE-DOSE | 2025-02-20 | No | No | Historical |