DOTAREM
- Product NDC
- 67684-2001
- 11-digit product format
- 676842001
- Labeler code
- 67684
- Product ID
- 67684-2001_313093fe-89fb-4ca8-973c-f36175bb47df
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gadoterate meglumine
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Guerbet LLC
- Application
- NDA204781
- Marketing category
- NDA
- Marketing start
- 2013-03-20
- 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
- DOTAREM
- 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#
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67684-2001 | DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC] | 25 | Current NDC, Legacy NDC, 8 package rows | 20250321_e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc.zip |
| 67684-2001 | DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC] | 17 | Current NDC, Legacy NDC, 2 package rows | 20250321_82b83e61-6af8-4225-aa39-8cbf206f65b0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67684-2001-0 | 67684200100 | 10 VIAL in 1 PACKAGE (67684-2001-0) / 5 mL in 1 VIAL | 10 vial | 2019-10-24 | 0000-00-00 | No | No | Current |
| 67684-2001-1 | 67684200101 | 10 VIAL in 1 PACKAGE (67684-2001-1) / 10 mL in 1 VIAL | 10 vial | 2019-10-24 | 0000-00-00 | No | No | Current |
| 67684-2001-2 | 67684200102 | 10 VIAL in 1 PACKAGE (67684-2001-2) / 15 mL in 1 VIAL | 10 vial | 2019-10-24 | 0000-00-00 | No | No | Current |
| 67684-2001-3 | 67684200103 | 10 VIAL in 1 PACKAGE (67684-2001-3) / 20 mL in 1 VIAL | 10 vial | 2019-10-24 | 0000-00-00 | No | No | Current |
| 67684-2001-4 | 67684200104 | 6 VIAL in 1 PACKAGE (67684-2001-4) / 100 mL in 1 VIAL | 6 vial | 2013-04-26 | 0000-00-00 | No | No | Current |