Prescription drug · NDA
Isovue-M (Iopamidol) NDC 0270-1411
Iopamidol 408 mg/mL · Injection, Solution · Intrathecal · Bracco Diagnostics Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0270-1411-11 | 0027014111100270141111 | 10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-1411-11) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 31, 1985 |
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)
- Isovue-M
- Generic name (nonproprietary)
- iopamidol
- Active ingredients
- Iopamidol — 408 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intrathecal
- Labeler
- Bracco Diagnostics IncNDC labeler code 0270
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018735
- Marketing start
- Listing expires
- Other FDA classes
- X-Ray Contrast Activity (Mechanism)
- Identifiers
- Product ID 0270-1411_07cc86aa-255e-f459-c9c5-747f57811163SPL ID 07cc86aa-255e-f459-c9c5-747f57811163SPL set ID 11e893d2-0183-4581-b908-c8b7302c7edbUNII JR13W81H44
- 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 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.
- NDC on a medical claim
N400270141111followed by a unit qualifier and the quantityPackage 00270-1411-11. 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 .
Indications (excerpt from the label)
ISOVUE-M is indicated for: Lumbar and thoracic myelography, and computed tomography (CT) myelography in adults and pediatric patients aged 2 years and older Cervical and total columnar myelography and CT myelography in adults CT cisternography in adults Specific concentrations of ISOVUE-M are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 )]. ISOVUE-M is a radiographic contrast agent indicated for: Lumbar and thoracic myelography and computed tomography (CT) myelography in adults and pediatric patients aged 2 years and older Cervical and total columnar myelography in adults CT cisternography in adults ( 1 ) Specific concentrations of ISOVUE-M are re…
Excerpt only. Read the full label for complete information.
About NDC 0270-1411
- What is NDC 0270-1411?
- 0270-1411 is the product NDC for Isovue-M (iopamidol), Iopamidol 408 mg/mL injection, solution, listed with the FDA by Bracco Diagnostics Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Isovue-M (Iopamidol).
- What is the active ingredient?
- Iopamidol.
- Who is the labeler?
- Bracco Diagnostics Inc, NDC labeler code 0270. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Isovue-M?
- 1 other product NDC are listed under this name. See all Isovue-M NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Isovue-M products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Isovue-Miopamidol | Iopamidol 612 mg/mL | Injection, SolutionIntrathecal | Bracco Diagnostics Inc | 0270-1412 | 00270-1412-15 |
Other NDCs under NDA 018735
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 |
|---|---|---|---|---|
| Isovue 200iopamidol | Iopamidol 408 mg/mL | Injection, SolutionIntravascular | BRACCO DIAGNOSTICS INC | 0270-1314 |
| Isovue 250iopamidol | Iopamidol 510 mg/mL | Injection, SolutionIntravascular | BRACCO DIAGNOSTICS INC | 0270-1317 |
| Isovue-Miopamidol | Iopamidol 612 mg/mL | Injection, SolutionIntrathecal | Bracco Diagnostics Inc | 0270-1412 |