NDC 67684-2001-01 - DOTAREM
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 67684-2001
- Requested NDC
- 67684-2001-01
- Package NDCs from labels
- 67684-2001-0, 67684-2001-1, 67684-2001-2, 67684-2001-3, 67684-2001-4, 67684-2001-01
- Manufacturer
- Guerbet LLC | Recipharm Monts | Simafex | PCAS Finland O.y | Liebel-Flarsheim Company LLC
- Effective date
- 2025-03-14
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| DOTAREM - Guerbet LLC | Recipharm Monts | Simafex | PCAS Finland O.y | Liebel-Flarsheim Company LLC | Guerbet LLC | Recipharm Monts | Simafex | PCAS Finland O.y | Liebel-Flarsheim Company LLC | 2025-03-14 | HUMAN PRESCRIPTION DRUG LABEL |
| DOTAREM - Guerbet LLC | Recipharm | Simafex | PCAS Finland O.y | Liebel-Flarsheim Company LLC | Guerbet LLC | Recipharm | Simafex | PCAS Finland O.y | Liebel-Flarsheim Company LLC | 2025-03-12 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67684-2001-0 | DOTAREM | 5 mL in 1 VIAL | INJECTION | 5 | 25 | |
| 67684-2001-0 | DOTAREM | 10 in 1 PACKAGE | INJECTION | 10 | 25 | |
| 67684-2001-1 | DOTAREM | 10 mL in 1 VIAL | INJECTION | 10 | 25 | |
| 67684-2001-1 | DOTAREM | 10 in 1 PACKAGE | INJECTION | 10 | 25 | |
| 67684-2001-2 | DOTAREM | 15 mL in 1 VIAL | INJECTION | 15 | 25 | |
| 67684-2001-2 | DOTAREM | 10 in 1 PACKAGE | INJECTION | 10 | 25 | |
| 67684-2001-3 | DOTAREM | 10 in 1 PACKAGE | INJECTION | 10 | 25 | |
| 67684-2001-3 | DOTAREM | 20 mL in 1 VIAL | INJECTION | 20 | 25 | |
| 67684-2001-4 | DOTAREM | 6 in 1 PACKAGE | Injection | 6 | 17 | |
| 67684-2001-4 | DOTAREM | 100 mL in 1 VIAL | Injection | 100 | 17 |
DailyMed Dashboard NDC Coverage#
| 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67684-2001-0 | ML - Milliliter | 67684-2001 | 1f220e99-64e2-4148-955f-dca63ea6b50a | 1 | 2021-01-08 |
| 67684-2001-2 | ML - Milliliter | 67684-2001 | e7a7902b-a16c-4df5-8ad0-f4f8027e1e25 | 1 | 2020-05-08 |
| 67684-2001-3 | ML - Milliliter | 67684-2001 | 42c3c966-345e-4ad6-bd46-3e1bcf66ce72 | 1 | 2020-05-08 |
| 67684-2001-4 | ML - Milliliter | 67684-2001 | cc518bb5-9b08-450b-aae7-bfb2ef445c4f | 1 | 2020-01-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| gadoterate meglumine | ACTIVE INGREDIENT | L0ND3981AG | DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC] | 3 | |
| GADOLINIUM CATION (3+) | ACTIVE MOIETY | AZV954TZ9N | DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC] | 3 | |
| gadoterate meglumine | ACTIVE INGREDIENT | L0ND3981AG | DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC] | 2 | |
| GADOLINIUM CATION (3+) | ACTIVE MOIETY | AZV954TZ9N | DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DOTAREM (GADOTERATE MEGLUMINE) INJECTION [GUERBET LLC] | 2 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Eyewash | EYEWASH | Global Equipment Company | c4f78121-4668-2e0c-e053-2995a90ab6c6 | 2021-06-17 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Asclemed USA, Inc. | 45c38269-883c-4198-a9d5-03810a4420ec | 2021-01-14 | Warnings, Adverse reactions | 059QF0KO0R |
| Bach Original Flower Remedies | WATER | Nelson Bach USA Limited | 09c76050-42c5-4403-865c-a1f6f668d9c0 | 2020-06-15 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Baxter Healthcare Company | 8bcf5572-49e1-4302-9522-56f57904cb4a | 2019-12-29 | Warnings, Adverse reactions | 059QF0KO0R |
| Dynamic Eyewash with Eyecup | WATER | Dynamic Safety International | 7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2 | 2018-12-17 | Warnings | 059QF0KO0R |
| Bio Rock Water | ROCK WATER | BioActive Nutritional, Inc. | 178bd16d-0d4f-49d8-866b-8ab3a3c6889d | 2018-07-30 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Baxter Healthcare Corporation | ef3e79c5-3f58-4b36-a296-64b7d9a651c1 | 2017-10-17 | Warnings, Adverse reactions | 059QF0KO0R |
| Eye Wash | WATER | CVS Pharmacy | 049cee29-7ec2-4d5b-8308-f522acde43a7 | 2017-03-29 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Baxter Healthcare Company | 210dc9ab-d6ca-4552-ac19-1be17792d290 | 2016-05-31 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.