ISOVUE
- Product NDC
- 0270-1317
- 11-digit product format
- 002701317
- Labeler code
- 0270
- Product ID
- 0270-1317_2cb2e0be-08b1-e446-01c5-b1c50f1e797c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IOPAMIDOL
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVASCULAR
- Labeler
- BRACCO DIAGNOSTICS INC
- Application
- NDA018735
- Marketing category
- NDA
- Marketing start
- 1985-12-31
- Substance
- IOPAMIDOL
- Active strength
- 510 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
- ISOVUE
- Brand name suffix
- 250
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IOPAMIDOL | 510 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 |
|---|
| 0270-1317-02 | ISOVUE250 | 100 mL in 1 BOTTLE | INJECTION, SOLUTION | 100 | | 22 |
| 0270-1317-02 | ISOVUE250 | 10 in 1 BOX | INJECTION, SOLUTION | 10 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IOPAMIDOL | ACTIVE INGREDIENT | JR13W81H44 | ISOVUE 200 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] | 7 | |
| IOPAMIDOL | ACTIVE MOIETY | JR13W81H44 | ISOVUE 200 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] | 7 | |
| EDETATE CALCIUM DISODIUM | INACTIVE INGREDIENT | 25IH6R4SGF | ISOVUE 200 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] | 7 | |
| TROMETHAMINE | INACTIVE INGREDIENT | 023C2WHX2V | ISOVUE 200 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0270-1317 | ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 200 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] | 19 | Current NDC, Legacy NDC, 2 package rows | 20250112_ae8c18c9-3e7d-4515-b980-120025a88fc1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0270-1317-02 | 00270131702 | 10 BOTTLE in 1 BOX (0270-1317-02) / 100 mL in 1 BOTTLE | 10 bottle | 1985-12-31 | 0000-00-00 | No | No | Current |
| 0270-1317-05 | 00270131705 | 10 VIAL, SINGLE-DOSE in 1 BOX (0270-1317-05) > 50 mL in 1 VIAL, SINGLE-DOSE | | 1985-12-31 | 0000-00-00 | No | No | Current |
| 0270-1317-09 | 00270131709 | 10 BOTTLE in 1 BOX (0270-1317-09) > 150 mL in 1 BOTTLE | 10 bottle | 1985-12-31 | 0000-00-00 | No | No | Current |
| 0270-1317-41 | 00270131741 | 10 BOTTLE in 1 BOX (0270-1317-41) > 200 mL in 1 BOTTLE | 10 bottle | 1994-10-12 | 2023-02-01 | No | No | Current |