Prescription drug · NDA
Omnipaque (Iohexol) NDC 0407-1415
Iohexol 9 mg/mL · Solution · Oral · GE Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0407-1415-09 | 0040714150900407141509 | 10 BOTTLE, PLASTIC in 1 BOX (0407-1415-09) / 500 mL in 1 BOTTLE, PLASTICMarketed from Apr 27, 2018 |
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)
- Omnipaque
- Generic name (nonproprietary)
- iohexol
- Active ingredients
- Iohexol — 9 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- GE Healthcare Inc.NDC labeler code 0407
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018956
- Marketing start
- Listing expires
- Other FDA classes
- X-Ray Contrast Activity (Mechanism)
- Identifiers
- Product ID 0407-1415_61f3e388-89bf-43d6-ad51-b620fff561fbSPL ID 61f3e388-89bf-43d6-ad51-b620fff561fbSPL set ID eee15ebe-d349-4497-acef-6abe7a8247fbUNII 4419T9MX03
- Pharmacologic class
- Radiographic 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400407141509followed by a unit qualifier and the quantityPackage 00407-1415-09. 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)
OMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. ( 1 ) 1.1 Intrathecal Procedures ‡ OMNIPAQUE is indicated for: Myelography and computerized tomography (CT) myelography (lumbar, thoracic, cervical, total columnar) in adults and pediatric patients aged 2 weeks and older CT cisternography in adults and pediatric patients aged 2 weeks and older 1.2 Intra-arterial Procedures ‡ OMNIPAQUE is indicated for: Cardiac ventriculography in adults and pediatric patients Aortography including studies of aorta and its branches in adults and pediatric patients …
Excerpt only. Read the full label for complete information.
About NDC 0407-1415
- What is NDC 0407-1415?
- 0407-1415 is the product NDC for Omnipaque (iohexol), Iohexol 9 mg/mL solution, listed with the FDA by GE Healthcare Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omnipaque (Iohexol).
- What is the active ingredient?
- Iohexol.
- 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 Omnipaque?
- 8 other product NDCs are listed under this name. See all Omnipaque NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Omnipaque products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Omnipaqueiohexol | Iohexol 12 mg/mL | SolutionOral | GE Healthcare Inc. | 0407-1416 | 00407-1416-12 |
| Omnipaqueiohexol | Iohexol 180 mg/mL | Injection, SolutionIntrathecal, Oral, Rectal | GE Healthcare Inc. | 0407-1411 | 00407-1411-10 |
| Omnipaqueiohexol | Iohexol 140 mg/mL | Injection, SolutionIntravascular, Intravenous | GE Healthcare Inc. | 0407-1401 | 00407-1401-52 |
| Omnipaqueiohexol | Iohexol 240 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | GE Healthcare Inc. | 0407-1412 | 00407-1412-1000407-1412-2000407-1412-30+1 more |
| Omnipaqueiohexol | Iohexol 300 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | GE Healthcare Inc. | 0407-1413 | 00407-1413-1000407-1413-5300407-1413-59+3 more |
| Omnipaqueiohexol | Iohexol 350 mg/mL | Injection, SolutionIntra-articular, Intravascular, Intravenous, Oral | GE Healthcare Inc. | 0407-1414 | 00407-1414-7600407-1414-8900407-1414-90+3 more |
| Omnipaqueiohexol | Iohexol 240 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | Medical Purchasing Solutions, LLC | 71872-7369 | 71872-7369-01 |
| Omnipaqueiohexol | Iohexol 300 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | Medical Purchasing Solutions, LLC | 71872-7370 | 71872-7370-01 |
Other NDCs under NDA 018956
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 |
|---|---|---|---|---|
| Omnipaqueiohexol | Iohexol 140 mg/mL | Injection, SolutionIntravascular, Intravenous | GE Healthcare Inc. | 0407-1401 |
| Omnipaqueiohexol | Iohexol 180 mg/mL | Injection, SolutionIntrathecal, Oral, Rectal | GE Healthcare Inc. | 0407-1411 |
| Omnipaqueiohexol | Iohexol 240 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | GE Healthcare Inc. | 0407-1412 |
| Omnipaqueiohexol | Iohexol 300 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | GE Healthcare Inc. | 0407-1413 |
| Omnipaqueiohexol | Iohexol 350 mg/mL | Injection, SolutionIntra-articular, Intravascular, Intravenous, Oral | GE Healthcare Inc. | 0407-1414 |
| Omnipaqueiohexol | Iohexol 12 mg/mL | SolutionOral | GE Healthcare Inc. | 0407-1416 |
| Omnipaqueiohexol | Iohexol 240 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | Medical Purchasing Solutions, LLC | 71872-7369 |
| Omnipaqueiohexol | Iohexol 300 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | Medical Purchasing Solutions, LLC | 71872-7370 |