ELUCIREM
- Product NDC
- 67684-4251
- 11-digit product format
- 676844251
- Labeler code
- 67684
- Product ID
- 67684-4251_e15d694f-7809-4715-a8c8-a432c05760cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gadopiclenol
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Guerbet LLC
- Application
- NDA216986
- Marketing category
- NDA
- Marketing start
- 2025-11-14
- Substance
- GADOPICLENOL
- Active strength
- 485.1 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ELUCIREM
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GADOPICLENOL | 485.1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S276568KOY |
DailyMed Product Concepts#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67684-4251-1 | 67684425101 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-1) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2025-11-14 | No | No | Current |
| 67684-4251-2 | 67684425102 | 25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-2) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2025-11-14 | No | No | Current |
| 67684-4251-3 | 67684425103 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-3) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2025-11-14 | No | No | Current |
| 67684-4251-4 | 67684425104 | 25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-4) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2025-11-14 | No | No | Current |
| 67684-4251-5 | 67684425105 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-5) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2025-11-14 | No | No | Current |
| 67684-4251-6 | 67684425106 | 6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-6) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2025-11-14 | No | No | Current |
| 67684-4251-7 | 67684425107 | 12 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-7) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2025-11-14 | No | No | Current |