ELUCIREM
- Product NDC
- 67684-4230
- 11-digit product format
- 676844230
- Labeler code
- 67684
- Product ID
- 67684-4230_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
- 2022-09-21
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67684-4230 | ELUCIREM (GADOPICLENOL) INJECTION [GUERBET LLC] | 7 | Current NDC, Legacy NDC | 20250311_ca582f31-1042-487f-82e4-533f1b541902.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67684-4230-1 | 67684423001 | 1 VIAL in 1 CARTON (67684-4230-1) / 3 mL in 1 VIAL | 1 vial | 2022-09-21 | 0000-00-00 | No | No | Current |
| 67684-4230-2 | 67684423002 | 10 VIAL in 1 CARTON (67684-4230-2) / 3 mL in 1 VIAL | 10 vial | 2022-09-21 | 0000-00-00 | No | No | Current |
| 67684-4230-3 | 67684423003 | 1 VIAL in 1 CARTON (67684-4230-3) > 7.5 mL in 1 VIAL | 1 vial | 2022-09-21 | 0000-00-00 | No | No | Current |
| 67684-4230-4 | 67684423004 | 10 VIAL in 1 CARTON (67684-4230-4) > 7.5 mL in 1 VIAL | 10 vial | 2022-09-21 | 0000-00-00 | No | No | Current |
| 67684-4230-5 | 67684423005 | 1 VIAL in 1 CARTON (67684-4230-5) > 10 mL in 1 VIAL | 1 vial | 2022-09-21 | 0000-00-00 | No | No | Current |
| 67684-4230-6 | 67684423006 | 10 VIAL in 1 CARTON (67684-4230-6) > 10 mL in 1 VIAL | 10 vial | 2022-09-21 | 0000-00-00 | No | No | Current |
| 67684-4230-7 | 67684423007 | 1 VIAL in 1 CARTON (67684-4230-7) > 15 mL in 1 VIAL | 1 vial | 2022-09-21 | 0000-00-00 | No | No | Current |
| 67684-4230-8 | 67684423008 | 10 VIAL in 1 CARTON (67684-4230-8) > 15 mL in 1 VIAL | 10 vial | 2022-09-21 | 0000-00-00 | No | No | Current |