iopamidol
- Product NDC
- 70436-124
- 11-digit product format
- 704360124
- Labeler code
- 70436
- Product ID
- 70436-124_16308b6e-8a2e-8431-e063-6294a90a986c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- iopamidol
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRATHECAL
- Labeler
- Slate Run Pharmaceuticals
- Application
- ANDA215382
- Marketing category
- ANDA
- Marketing start
- 2023-07-20
- Substance
- IOPAMIDOL
- Active strength
- 408 mg/mL
- Pharmacologic classes
- Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- iopamidol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IOPAMIDOL | 408 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JR13W81H44 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70436-124-33 | iopamidol | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 5 |
| 70436-124-35 | iopamidol | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 20 | | 5 |
| 70436-124-52 | iopamidol | 200 mL in 1 CARTON | INJECTION, SOLUTION | 200 | | 5 |
| 70436-124-82 | iopamidol | 100 mL in 1 CARTON | INJECTION, SOLUTION | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70436-124 | IOPAMIDOL INJECTION, SOLUTION [SLATE RUN PHARMACEUTICALS] | 5 | Current NDC, 4 package rows | 20240418_0b9e0d24-c6ca-4e22-9422-936e9d475eaa.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70436-124-33 | 70436012433 | 10 mL in 1 VIAL, SINGLE-DOSE (70436-124-33) | 10 ml | 2023-07-20 | No | No | Historical |
| 70436-124-35 | 70436012435 | 20 mL in 1 VIAL, SINGLE-DOSE (70436-124-35) | 20 ml | 2023-07-20 | No | No | Historical |
| 70436-124-52 | 70436012452 | 200 mL in 1 CARTON (70436-124-52) | 200 ml | 2023-07-20 | No | No | Historical |
| 70436-124-82 | 70436012482 | 100 mL in 1 CARTON (70436-124-82) | 100 ml | 2023-07-20 | No | No | Historical |