Prescription drug · NDA

Isovue 370 (iopamidol) NDC 0270-1316

Iopamidol 755 mg/mL · Injection, Solution · Intravascular · BRACCO DIAGNOSTICS INC

NDC codes

FDA NDC Directory
Product NDC (as listed)0270-1316Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00270-1316Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0270-1316-040027013160410 BOTTLE in 1 BOX (0270-1316-04) / 125 mL in 1 BOTTLEMarketed from Dec 31, 1985
0270-1316-300027013163010 VIAL in 1 BOX (0270-1316-30) / 50 mL in 1 VIALMarketed from Dec 31, 1985
0270-1316-350027013163510 BOTTLE in 1 BOX (0270-1316-35) / 100 mL in 1 BOTTLEMarketed from Dec 31, 1985
0270-1316-370027013163710 BOTTLE in 1 BOX (0270-1316-37) / 150 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 370Suffix: 370
Generic name (nonproprietary)
iopamidol
Active ingredients
Iopamidol — 755 mg/mL
Dosage form
Injection, Solution
Route
Intravascular
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 0270-1316_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

N400270131604 followed by a unit qualifier and the quantity

Package 00270-1316-04. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under NDA 018735

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 018735
ProductStrengthForm · routeLabelerProduct NDC
Isovue-MiopamidolIopamidol 612 mg/mLInjection, SolutionIntrathecalBracco Diagnostics Inc0270-1412
Isovue 200iopamidolIopamidol 408 mg/mLInjection, SolutionIntravascularBRACCO DIAGNOSTICS INC0270-1314
Isovue 300iopamidolIopamidol 612 mg/mLInjection, SolutionIntravascularBRACCO DIAGNOSTICS INC0270-1315
Isovue 250iopamidolIopamidol 510 mg/mLInjection, SolutionIntravascularBRACCO DIAGNOSTICS INC0270-1317
Isovue-MiopamidolIopamidol 408 mg/mLInjection, SolutionIntrathecalBracco Diagnostics Inc0270-1411

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