Prescription drug · ANDA
iopamidol NDC 70436-125
Iopamidol 510 mg/mL · Injection, Solution · Intravascular · Slate Run Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70436-125-82 | 70436012582 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-125-82) / 50 mL in 1 VIAL, SINGLE-DOSE (70436-125-37)Marketed from Apr 15, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- iopamidol
- Generic name (nonproprietary)
- iopamidol
- Active ingredients
- Iopamidol — 510 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravascular
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217134
- Marketing start
- Listing expires
- Other FDA classes
- X-Ray Contrast Activity (Mechanism)
- Identifiers
- Product ID 70436-125_3a1c5a58-814e-8d80-e063-6394a90ac71dSPL ID 3a1c5a58-814e-8d80-e063-6394a90ac71dSPL set ID 69e9ab05-88f8-45f9-8bc1-ed33ab1385f0UNII 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
N470436012582followed by a unit qualifier and the quantityPackage 70436-0125-82. 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)
Iopamidol Injection, USP 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* Cerebral arteriography in adults Periphe…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217134
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 |
|---|---|---|---|---|
| iopamidol | Iopamidol 408 mg/mL | Injection, SolutionIntravascular | Slate Run Pharmaceuticals, LLC | 70436-211 |
| iopamidol | Iopamidol 612 mg/mL | Injection, SolutionIntravascular | Slate Run Pharmaceuticals, LLC | 70436-219 |
| iopamidol | Iopamidol 755 mg/mL | Injection, SolutionIntravascular | Slate Run Pharmaceuticals, LLC | 70436-127 |