Gadoterate Meglumine
- Product NDC
- 65219-080
- 11-digit product format
- 652190080
- Labeler code
- 65219
- Product ID
- 65219-080_f05922b7-99d4-48c7-972a-7966bbbbc3b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gadoterate meglumine
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA215304
- Marketing category
- ANDA
- Marketing start
- 2022-06-20
- Substance
- GADOTERATE MEGLUMINE
- Active strength
- 376.9 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
- Gadoterate Meglumine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GADOTERATE MEGLUMINE | 376.9 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L0ND3981AG |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-080-01 | Gadoterate Meglumine | 5 mL in 1 VIAL | INJECTION | 5 | | 4 |
| 65219-080-01 | Gadoterate Meglumine | 1 in 1 CARTON | INJECTION | 1 | | 4 |
| 65219-080-05 | Gadoterate Meglumine | 10 in 1 BOX | INJECTION | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-080 | GADOTERATE MEGLUMINE INJECTION [FRESENIUS KABI USA, LLC] | 3 | Current NDC, Legacy NDC, 3 package rows | 20240217_e0655aac-9508-4141-94f5-fcca6af1c41d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65219-080-01 | 65219008001 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 65219-080-05 | 65219008005 | 10 CARTON in 1 BOX (65219-080-05) / 1 VIAL in 1 CARTON (65219-080-01) / 5 mL in 1 VIAL | 10 carton | 2022-06-20 | 0000-00-00 | No | No | Current |