Prescription drug · NDA
Isovue 200 (iopamidol) NDC 0270-1314
Iopamidol 408 mg/mL · Injection, Solution · Intravascular · BRACCO DIAGNOSTICS INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0270-1314-15 | 00270131415 | 10 BOTTLE in 1 BOX (0270-1314-15) / 200 mL in 1 BOTTLEMarketed 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 200Suffix: 200
- Generic name (nonproprietary)
- iopamidol
- Active ingredients
- Iopamidol — 408 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravascular
- Labeler
- BRACCO DIAGNOSTICS INC
- 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 0270-1314_2cb2e0be-08b1-e446-01c5-b1c50f1e797cSPL ID 2cb2e0be-08b1-e446-01c5-b1c50f1e797cSPL set ID ae8c18c9-3e7d-4515-b980-120025a88fc1UNII 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
N400270131415followed by a unit qualifier and the quantityPackage 00270-1314-15. 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)
ISOVUE is a radiographic contrast agent indicated for: Intra-arterial Procedures † ( 1.1 ) Cerebral arteriography in adults Peripheral arteriography in adults Selective visceral arteriography and aortography in adults Coronary arteriography and cardiac ventriculography in adults Angiocardiography in pediatric patients Intravenous Procedures † ( 1.2 ) Excretory urography in adults and pediatric patients Computed tomography (CT) of head and body in adults and pediatric patients Peripheral venography in adults Oral Procedures † ( 1.3 ) CT of the abdomen and pelvis to delineate the gastrointestinal tract in adults and pediatric patients † Specific concentrations are recommended for each type of …
Excerpt only. Read the full label for complete information.
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-Miopamidol | Iopamidol 612 mg/mL | Injection, SolutionIntrathecal | Bracco Diagnostics Inc | 0270-1412 |
| Isovue 300iopamidol | Iopamidol 612 mg/mL | Injection, SolutionIntravascular | BRACCO DIAGNOSTICS INC | 0270-1315 |
| Isovue 370iopamidol | Iopamidol 755 mg/mL | Injection, SolutionIntravascular | BRACCO DIAGNOSTICS INC | 0270-1316 |
| Isovue 250iopamidol | Iopamidol 510 mg/mL | Injection, SolutionIntravascular | BRACCO DIAGNOSTICS INC | 0270-1317 |
| Isovue-Miopamidol | Iopamidol 408 mg/mL | Injection, SolutionIntrathecal | Bracco Diagnostics Inc | 0270-1411 |