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 |
|---|---|---|---|---|---|---|
| Kollourion Eyesalve Eyewash | PURIFIED WATER 98.3% | Miracle Eye Pharmaceuticals | b56d2ab9-169b-b490-e053-2a95a90a80b3 | 2025-12-28 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | ProPharma Distribution | 386a0a2f-4ff7-f128-e063-6294a90a7d4d | 2025-12-18 | Warnings, Adverse reactions | 059QF0KO0R |
| Firstep Firstflush | EYEWASH | Encon Safety Products, Inc. | a44beb26-79ae-98bd-e053-2995a90a9b74 | 2025-12-09 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | beda35c3-9a8b-47ad-e053-2995a90a7b1b | 2025-11-24 | Warnings | 059QF0KO0R |
| Easy Care First Aid Eyewash | WATER | Tender Corporation | a070aac8-e6d2-ef10-e053-2a95a90aa5b1 | 2025-11-24 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | e07a064b-f680-405c-bbcd-24fac430951e | 2025-11-24 | Warnings | 059QF0KO0R |
| ULINE Eyewash | EYEWASH | Niagara Pharmaceuticals Inc. | 2d7f22d2-320b-6af1-e063-6294a90addc6 | 2025-11-24 | Warnings | 059QF0KO0R |
| Pur-Wash | EYEWASH | Niagara Pharmaceuticals, Inc. | 0d43b1c1-2699-37f1-e054-00144ff88e88 | 2025-11-24 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | 777e1559-786f-8d54-e053-2991aa0aa98d | 2025-11-24 | Warnings | 059QF0KO0R |
| PUR-WASH | WATER | Niagara Pharmaceuticals Inc. | 7289103a-5cbf-42f4-8848-e827149a43ca | 2025-11-24 | Warnings | 059QF0KO0R |
| Eyewash Additive Concentrate | WATER AND PROPYLENE GLYCOL | Haws Corporation | dd168403-398c-41ff-b1df-d93e4ff39de3 | 2025-11-20 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | fd823bef-c14c-4708-a18a-8aaa8470412f | 2025-11-18 | Warnings, Adverse reactions | 059QF0KO0R |
| Eyesaline Eyewash Concentrate | PURIFIED WATER | Honeywell Safety Products USA, Inc. | 3765c251-eb14-d60f-e063-6294a90a6a4d | 2025-11-12 | Warnings | 059QF0KO0R |
| Eyesaline Emergency Eyewash | PURIFIED WATER | Honeywell Safety Products USA, Inc. | 37f244fd-c02f-e66a-e063-6394a90aed81 | 2025-11-12 | Warnings | 059QF0KO0R |
| STERILE WATER | WATER | Henry Schein, Inc. | f4087143-9868-4308-b96c-43657ee8ec28 | 2025-11-07 | Warnings, Adverse reactions | 059QF0KO0R |
| Gadoterate Meglumine | GADOTERATE MEGLUMINE | Fresenius Kabi USA, LLC | fbebe7f2-a0c2-4fd5-b421-8fbcbaf46709 | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | L0ND3981AG |
| Gadoterate Meglumine | GADOTERATE MEGLUMINE | Fresenius Kabi USA, LLC | e0655aac-9508-4141-94f5-fcca6af1c41d | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | L0ND3981AG |
| Bacteriostatic Water | BACTERIOSTATIC WATER | ProPharma Distribution | 42c6938e-f747-ae13-e063-6294a90a59a3 | 2025-11-04 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | ICU Medical Inc. | aab10f03-26ae-4dbc-a481-ef025e48b405 | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | ICU Medical Inc. | e3484bc6-ed7f-43ef-9d49-c131a8dff2dd | 2025-11-02 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.