Ultravist
- Product NDC
- 50419-342
- 11-digit product format
- 504190342
- Labeler code
- 50419
- Product ID
- 50419-342_8cd922ce-ced7-4c4a-a104-c54be40e8a0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- iopromide
- Dosage form
- INJECTION
- Route
- INTRA-ARTERIAL; INTRAVENOUS
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.
- Application
- NDA020220
- Marketing category
- NDA
- Marketing start
- 2009-12-30
- Marketing end
- 2021-01-03
- Substance
- IOPROMIDE
- Active strength
- 240 mg/mL
- Pharmacologic classes
- Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 77dc03a4-fbfc-e6a3-fe95-285bbae40d75 | Product name | 2 | 20250814 |
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
| 5f30b278-5791-4113-8781-878a9221ef8a | Product name | 2 | 20230125 |
| 2a70c781-a755-4d76-b20a-a958acfbdcdc | Product name | 2 | 20190619 |
| 304592ef-4a8a-4c22-8e8c-af73aa3d60e5 | Product name | 1 | 20180703 |
| ac0821a1-ce75-4ea7-880a-59eecaecdf22 | Product name | 1 | 20180703 |
| db5dc4f9-b907-46f6-8fb7-babcf04bbe5c | Product name | 1 | 20180619 |
| 41e9d6cf-3ed7-4c44-a57e-0685058d0896 | Product name | 1 | 20170824 |
| 5e652c92-68fd-426b-b0e7-5fc64e0b9f99 | Product name | 1 | 20170309 |
| ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c | Product name | 1 | 20150421 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50419-342-05 | Ultravist | 10 in 1 CARTON | INJECTION | 10 | 25 | |
| 50419-342-05 | Ultravist | 50 mL in 1 VIAL, GLASS | INJECTION | 50 | 25 | |
| 50419-342-10 | Ultravist | 10 in 1 CARTON | INJECTION | 10 | 25 | |
| 50419-342-10 | Ultravist | 100 mL in 1 VIAL, GLASS | INJECTION | 100 | 25 | |
| 50419-342-21 | Ultravist | 200 mL in 1 BOTTLE | INJECTION | 200 | 25 | |
| 50419-342-21 | Ultravist | 10 in 1 PACKAGE | INJECTION | 10 | 25 | |
| 50419-342-41 | Ultravist | 50 mL in 1 VIAL, GLASS | INJECTION | 50 | 25 | |
| 50419-342-41 | Ultravist | 10 in 1 CARTON | INJECTION | 10 | 25 | |
| 50419-342-43 | Ultravist | 100 mL in 1 VIAL, GLASS | INJECTION | 100 | 25 | |
| 50419-342-43 | Ultravist | 10 in 1 CARTON | INJECTION | 10 | 25 | |
| 50419-342-21 | Ultravist | 10 in 1 PACKAGE | INJECTION | 10 | 22 | |
| 50419-342-21 | Ultravist | 200 mL in 1 BOTTLE | INJECTION | 200 | 22 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50419-342-05 | ML - Milliliter | 50419-342 | ca74ffd8-d4f2-4f3b-b526-ab8fa9d7d3eb | 1 | 2012-07-24 |
| 50419-342-10 | ML - Milliliter | 50419-342 | 8edc0952-df59-4ec6-848b-6e6f9c0e6b03 | 1 | 2012-07-24 |
| 50419-342-15 | ML - Milliliter | 50419-342 | 756061c0-ced4-45d1-a272-600b8104da5d | 1 | 2013-03-03 |
| 50419-342-21 | ML - Milliliter | 50419-342 | 34408919-d699-4b02-8ee1-8e414e1028da | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50419-342 | ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 22 | Legacy NDC, 10 package rows | 20240822_df917c3a-59a2-4ed1-8470-8a5394c73325.zip |
| 50419-342 | ULTRAVIST (IOPROMIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 22 | Legacy NDC, 2 package rows | 20230515_d96a7883-d160-40a1-bdbd-2e8d7877cd18.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 50419-342-05 | 50419034205 | 10 in 1 CARTON | Historical | |
| 50419-342-10 | 50419034210 | 10 in 1 CARTON | Historical | |
| 50419-342-21 | 50419034221 | 200 mL in 1 BOTTLE | 200 ml | Historical |
| 50419-342-41 | 50419034241 | 50 mL in 1 VIAL, GLASS | 50 ml | Historical |
| 50419-342-43 | 50419034243 | 100 mL in 1 VIAL, GLASS | 100 ml | Historical |