Prescription drug · NDA
Dotarem (Gadoterate meglumine) NDC 67684-2001
Gadoterate meglumine 376.9 mg/mL · Injection · Intravenous · Guerbet LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67684-2001-0 | 6768420010067684200100 | 10 VIAL in 1 PACKAGE (67684-2001-0) / 5 mL in 1 VIALMarketed from Oct 24, 2019 | |
| 67684-2001-1 | 6768420010167684200101 | 10 VIAL in 1 PACKAGE (67684-2001-1) / 10 mL in 1 VIALMarketed from Oct 24, 2019 | |
| 67684-2001-2 | 6768420010267684200102 | 10 VIAL in 1 PACKAGE (67684-2001-2) / 15 mL in 1 VIALMarketed from Oct 24, 2019 | |
| 67684-2001-3 | 6768420010367684200103 | 10 VIAL in 1 PACKAGE (67684-2001-3) / 20 mL in 1 VIALMarketed from Oct 24, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Dotarem
- Generic name (nonproprietary)
- gadoterate meglumine
- Active ingredients
- Gadoterate meglumine — 376.9 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Guerbet LLCNDC labeler code 67684
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204781
- Marketing start
- Listing expires
- Other FDA classes
- Magnetic Resonance Contrast Activity (Mechanism)
- Identifiers
- Product ID 67684-2001_313093fe-89fb-4ca8-973c-f36175bb47dfSPL ID 313093fe-89fb-4ca8-973c-f36175bb47dfSPL set ID e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebcUNII L0ND3981AGUPC 0367684200110, 0367684300124, 0367684300117, 0367684300131, 0367684200103, 0367684200134, 0367684200127
- Pharmacologic class
- Gadolinium-based Contrast Agent
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N467684200100followed by a unit qualifier and the quantityPackage 67684-2001-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
Excerpt only. Read the full label for complete information.
About NDC 67684-2001
- What is NDC 67684-2001?
- 67684-2001 is the product NDC for Dotarem (gadoterate meglumine), Gadoterate meglumine 376.9 mg/mL injection, listed with the FDA by Guerbet LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dotarem (Gadoterate meglumine).
- What is the active ingredient?
- Gadoterate meglumine.
- Who is the labeler?
- Guerbet LLC, NDC labeler code 67684. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dotarem?
- 2 other product NDCs are listed under this name. See all Dotarem NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dotarem products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dotaremgadoterate meglumine | Gadoterate meglumine 376.9 mg/mL | InjectionIntravenous | Guerbet LLC | 67684-3001 | 67684-3001-0167684-3001-0267684-3001-03 |
| Dotaremgadoterate meglumine | Gadoterate meglumine 376.9 mg/mL | InjectionIntravenous | Guerbet LLC | 67684-2000 | 67684-2000-0067684-2000-0167684-2000-02+1 more |
Other NDCs under NDA 204781
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dotaremgadoterate meglumine | Gadoterate meglumine 376.9 mg/mL | InjectionIntravenous | Guerbet LLC | 67684-2000 |
| Dotaremgadoterate meglumine | Gadoterate meglumine 376.9 mg/mL | InjectionIntravenous | Guerbet LLC | 67684-3001 |