Iohexol
- Product NDC
- 80830-2468
- 11-digit product format
- 808302468
- Labeler code
- 80830
- Product ID
- 80830-2468_ff93b085-67bb-4fef-b6b7-37dd845171e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Iohexol
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL
- Labeler
- Amneal Pharmaceuticals Private Limited
- Application
- ANDA217737
- Marketing category
- ANDA
- Marketing start
- 2025-11-13
- Substance
- IOHEXOL
- Active strength
- 300 mg/mL
- Pharmacologic classes
- Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Iohexol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IOHEXOL | 300 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4419T9MX03 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80830-2468-1 | Iohexol | 100 mL in 1 BOTTLE, PLASTIC | INJECTION, SOLUTION | 100 | | 9 |
| 80830-2468-2 | Iohexol | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 9 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80830-2468-1 | 80830246801 | 100 mL in 1 BOTTLE, PLASTIC | 100 ml | | | | Historical |
| 80830-2468-2 | 80830246802 | 10 BOTTLE, PLASTIC in 1 CARTON (80830-2468-2) / 100 mL in 1 BOTTLE, PLASTIC (80830-2468-1) | | 2025-11-13 | No | No | Historical |