Prescription drug · ANDA
Iohexol NDC 80830-2467
Iohexol 300 mg/mL · Injection, Solution · Intra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal · Amneal Pharmaceuticals Private Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80830-2467-2 | 8083024670280830246702 | 10 BOTTLE, PLASTIC in 1 CARTON (80830-2467-2) / 75 mL in 1 BOTTLE, PLASTIC (80830-2467-1)Marketed from Nov 13, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Iohexol
- Generic name (nonproprietary)
- iohexol
- Active ingredients
- Iohexol — 300 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal
- Labeler
- Amneal Pharmaceuticals Private LimitedNDC labeler code 80830
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217737
- Marketing start
- Listing expires
- Other FDA classes
- X-Ray Contrast Activity (Mechanism)
- Identifiers
- Product ID 80830-2467_d73504e3-4f96-4751-ae9f-fa6201b28640SPL ID d73504e3-4f96-4751-ae9f-fa6201b28640SPL set ID ff9456ef-c45a-450d-9004-a684af2bcc59UNII 4419T9MX03
- 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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N480830246702followed by a unit qualifier and the quantityPackage 80830-2467-02. 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)
Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity imaging procedures in adults and pediatric patients. ( 1 ) 1.1 Intrathecal Procedures ‡ Iohexol injection is indicated for: Myelography and computerized tomography (CT) myelography (lumbar, thoracic, cervical, total columnar) in adults and pediatric patients aged 2 weeks and older CT cisternography in adults and pediatric patients aged 2 weeks and older 1.2 Intra-arterial Procedures ‡ Iohexol injection is indicated for: Cardiac ventriculography in adults and pediatric patients Aortography including studies of aorta and its branches in adults and pediat…
Excerpt only. Read the full label for complete information.
About NDC 80830-2467
- What is NDC 80830-2467?
- 80830-2467 is the product NDC for Iohexol, Iohexol 300 mg/mL injection, solution, listed with the FDA by Amneal Pharmaceuticals Private Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Iohexol.
- What is the active ingredient?
- Iohexol.
- Who is the labeler?
- Amneal Pharmaceuticals Private Limited, NDC labeler code 80830. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Iohexol?
- 5 other product NDCs are listed under this name. See all Iohexol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Iohexol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Iohexol | Iohexol 300 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | Amneal Pharmaceuticals Private Limited | 80830-2466 | 80830-2466-02 |
| Iohexol | Iohexol 350 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | Amneal Pharmaceuticals Private Limited | 80830-2471 | 80830-2471-02 |
| Iohexol | Iohexol 350 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | Amneal Pharmaceuticals Private Limited | 80830-2472 | 80830-2472-02 |
| Iohexol | Iohexol 350 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | Amneal Pharmaceuticals Private Limited | 80830-2473 | 80830-2473-02 |
| Iohexol | Iohexol 300 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | Amneal Pharmaceuticals Private Limited | 80830-2468 | 80830-2468-02 |
Other NDCs under ANDA 217737
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 |
|---|---|---|---|---|
| Iohexol | Iohexol 300 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | Amneal Pharmaceuticals Private Limited | 80830-2466 |
| Iohexol | Iohexol 300 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | Amneal Pharmaceuticals Private Limited | 80830-2468 |
| Iohexol | Iohexol 350 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | Amneal Pharmaceuticals Private Limited | 80830-2471 |
| Iohexol | Iohexol 350 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | Amneal Pharmaceuticals Private Limited | 80830-2472 |
| Iohexol | Iohexol 350 mg/mL | Injection, SolutionIntra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal | Amneal Pharmaceuticals Private Limited | 80830-2473 |