Prescription drug · NDA
Isovue 300 (Iopamidol) NDC 0270-1315
Iopamidol 612 mg/mL · Injection, Solution · Intravascular · Bracco Diagnostics Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0270-1315-45 | 0027013154500270131545 | 10 BOTTLE in 1 BOX (0270-1315-45) / 200 mL in 1 BOTTLEMarketed from Jun 20, 2014 | |
| 0270-1315-95 | 0027013159500270131595 | 6 BOTTLE in 1 BOX (0270-1315-95) / 500 mL in 1 BOTTLEMarketed from Jun 20, 2014 |
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 300Suffix: 300
- Generic name (nonproprietary)
- iopamidol
- Active ingredients
- Iopamidol — 612 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravascular
- Labeler
- Bracco Diagnostics IncNDC labeler code 0270
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020327
- Marketing start
- Listing expires
- Other FDA classes
- X-Ray Contrast Activity (Mechanism)
- Identifiers
- Product ID 0270-1315_c31a9ece-7b14-abe3-6214-f4e8c482516cSPL ID c31a9ece-7b14-abe3-6214-f4e8c482516cSPL set ID 797a11d7-dcd4-43ff-311b-3b48a10da2f2UNII 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
N400270131545followed by a unit qualifier and the quantityPackage 00270-1315-45. 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 † Specific concentrations are recommended for each type of imaging procedure. ( 2.2 , 2.3 , 2.4 ) 1.1 Intra-arterial Procedures † ISOVUE is indicated for: Cerebral arteriography in adults…
Excerpt only. Read the full label for complete information.
About NDC 0270-1315
- What is NDC 0270-1315?
- 0270-1315 is the product NDC for Isovue 300 (iopamidol), Iopamidol 612 mg/mL injection, solution, listed with the FDA by Bracco Diagnostics Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Isovue 300 (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 300?
- 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.
Other NDCs under NDA 020327
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 370iopamidol | Iopamidol 755 mg/mL | Injection, SolutionIntravascular | Bracco Diagnostics Inc | 0270-1316 |