iopamidol
- Product NDC
- 70436-211
- 11-digit product format
- 704360211
- Labeler code
- 70436
- Product ID
- 70436-211_3a1c5a58-814e-8d80-e063-6394a90ac71d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- iopamidol
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVASCULAR
- Labeler
- Slate Run Pharmaceuticals, LLC
- Application
- ANDA217134
- Marketing category
- ANDA
- Marketing start
- 2024-04-15
- 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 |
|---|
| 70436-211-37 | iopamidol | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 50 | | 3 |
| 70436-211-80 | iopamidol | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70436-211 | IOPAMIDOL INJECTION, SOLUTION [SLATE RUN PHARMACEUTICALS, LLC] | 2 | Current NDC, 2 package rows | 20240420_69e9ab05-88f8-45f9-8bc1-ed33ab1385f0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70436-211-37 | 70436021137 | 50 mL in 1 VIAL, SINGLE-DOSE | 50 ml | | | | Historical |
| 70436-211-80 | 70436021180 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70436-211-80) / 50 mL in 1 VIAL, SINGLE-DOSE (70436-211-37) | | 2024-04-15 | No | No | Historical |