Prescription drug · NDA
Omniscan (Gadodiamide) NDC 0407-0690
Gadodiamide 287 mg/mL · Injection · Intravenous · GE Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0407-0690-10 | 00407069010 | 10 VIAL in 1 BOX (0407-0690-10) / 10 mL in 1 VIALMarketed from Apr 19, 2002 | |
| 0407-0690-15 | 00407069015 | 10 VIAL in 1 BOX (0407-0690-15) / 15 mL in 1 VIALMarketed from Apr 19, 2002 | |
| 0407-0690-20 | 00407069020 | 10 VIAL in 1 BOX (0407-0690-20) / 20 mL in 1 VIALMarketed from Apr 19, 2002 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Omniscan
- Generic name (nonproprietary)
- gadodiamide
- Active ingredients
- Gadodiamide — 287 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- GE Healthcare Inc.NDC labeler code 0407
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020123
- Marketing start
- Listing expires
- Other FDA classes
- Magnetic Resonance Contrast Activity (Mechanism)
- Identifiers
- Product ID 0407-0690_dfe2f58c-7a8f-408a-9690-6300a49eda17SPL ID dfe2f58c-7a8f-408a-9690-6300a49eda17SPL set ID 1e9a37e2-f28a-4373-bf0f-3e9b60f42d8aUNII 84F6U3J2R6
- Pharmacologic class
- Paramagnetic 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
N400407069010followed by a unit qualifier and the quantityPackage 00407-0690-10. 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)
OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues ( 1.1 ) Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space ( 1.2 ) 1.1 CNS (Central Nervous System) OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues [see Clinical Studies (1…
Excerpt only. Read the full label for complete information.
About NDC 0407-0690
- What is NDC 0407-0690?
- 0407-0690 is the product NDC for Omniscan (gadodiamide), Gadodiamide 287 mg/mL injection, listed with the FDA by GE Healthcare Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omniscan (Gadodiamide).
- What is the active ingredient?
- Gadodiamide.
- Who is the labeler?
- GE Healthcare Inc., NDC labeler code 0407. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Omniscan?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.