ISOVUE-M 200
- Product NDC
- 52584-411
- 11-digit product format
- 525840411
- Labeler code
- 52584
- Product ID
- 52584-411_ca95a1e5-fe0b-437f-b643-86e0bb6fe999
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Iopamidol
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRATHECAL
- Labeler
- General Injectables & Vaccines, Inc.
- Application
- NDA018735
- Marketing category
- NDA
- Marketing start
- 2010-11-05
- Marketing end
- 0000-00-00
- Substance
- IOPAMIDOL
- Active strength
- 408 mg/mL
- Pharmacologic classes
- Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52584-411-11 | ISOVUE-M 200 | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 3 |
| 52584-411-11 | ISOVUE-M 200 | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Iopamidol | ACTIVE INGREDIENT | JR13W81H44 | ISOVUE-M 200 (IOPAMIDOL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.] | 2 | |
| Iopamidol | ACTIVE MOIETY | JR13W81H44 | ISOVUE-M 200 (IOPAMIDOL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.] | 2 | |
| Edetate Calcium Disodium | INACTIVE INGREDIENT | 25IH6R4SGF | ISOVUE-M 200 (IOPAMIDOL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.] | 2 | |
| Tromethamine | INACTIVE INGREDIENT | 023C2WHX2V | ISOVUE-M 200 (IOPAMIDOL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52584-411 | ISOVUE-M 200 (IOPAMIDOL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.] | 3 | Legacy NDC, 2 package rows | 20170118_60979ac0-024e-4dc8-9a84-c9195093c08d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 52584-411-11 | 52584041111 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | Historical |