Prescription drug · ANDA
iopamidol NDC 70436-126
Iopamidol 612 mg/mL · Injection, Solution · Intrathecal · Slate Run Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70436-126-34 | 7043601263470436012634 | 15 mL in 1 VIAL, SINGLE-DOSE (70436-126-34)Marketed from Jul 20, 2023 | |
| 70436-126-82 | 7043601268270436012682 | 150 mL in 1 CARTON (70436-126-82)Marketed from Jul 20, 2023 |
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 — 612 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intrathecal
- Labeler
- Slate Run Pharmaceuticals, LLCNDC labeler code 70436
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215382
- Marketing start
- Listing expires
- Other FDA classes
- X-Ray Contrast Activity (Mechanism)
- Identifiers
- Product ID 70436-126_5821e051-f3a4-b435-e063-6294a90a62b9SPL ID 5821e051-f3a4-b435-e063-6294a90a62b9SPL set ID 0b9e0d24-c6ca-4e22-9422-936e9d475eaaUNII JR13W81H44UPC 0370436126828, 0370436124824, 0370436124527
- 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
N470436012634followed by a unit qualifier and the quantityPackage 70436-0126-34. 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)
Iopamidol injection for intrathecal administration 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 iopamidol injection are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 )]. Iopamidol injection 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 cisternog…
Excerpt only. Read the full label for complete information.
About NDC 70436-126
- What is NDC 70436-126?
- 70436-126 is the product NDC for iopamidol, Iopamidol 612 mg/mL injection, solution, listed with the FDA by Slate Run Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- iopamidol.
- What is the active ingredient?
- Iopamidol.
- Who is the labeler?
- Slate Run Pharmaceuticals, LLC, NDC labeler code 70436. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for iopamidol?
- 5 other product NDCs are listed under this name. See all iopamidol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other iopamidol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| iopamidol | Iopamidol 510 mg/mL | Injection, SolutionIntravascular | Slate Run Pharmaceuticals, LLC | 70436-125 | 70436-0125-82 |
| iopamidol | Iopamidol 755 mg/mL | Injection, SolutionIntravascular | Slate Run Pharmaceuticals, LLC | 70436-127 | 70436-0127-5270436-0127-6270436-0127-82 |
| iopamidol | Iopamidol 408 mg/mL | Injection, SolutionIntravascular | Slate Run Pharmaceuticals, LLC | 70436-211 | 70436-0211-80 |
| iopamidol | Iopamidol 612 mg/mL | Injection, SolutionIntravascular | Slate Run Pharmaceuticals, LLC | 70436-219 | 70436-0219-5270436-0219-6270436-0219-82 |
| iopamidol | Iopamidol 408 mg/mL | Injection, SolutionIntrathecal | Slate Run Pharmaceuticals, LLC | 70436-124 | 70436-0124-3370436-0124-3570436-0124-52+1 more |
Other NDCs under ANDA 215382
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, SolutionIntrathecal | Slate Run Pharmaceuticals, LLC | 70436-124 |