Visudyne
- Product NDC
- 0187-5600
- 11-digit product format
- 001875600
- Labeler code
- 0187
- Product ID
- 0187-5600_3d5b1ecb-4d6e-8696-e063-6394a90adf2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- verteporfin for injection
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Bausch Health US LLC
- Application
- NDA021119
- Marketing category
- NDA
- Marketing start
- 2000-04-12
- Marketing end
- 2027-12-01
- Substance
- VERTEPORFIN
- Active strength
- 15 mg/1
- Pharmacologic classes
- Photoabsorption [MoA], Photoenhancer [EPC], Photosensitizing Activity [PE]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Visudyne
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VERTEPORFIN | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0X9PA28K43 |
| Rxcui | 313595, 351914 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0187-5600-15 | Visudyne | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| VERTEPORFIN | ACTIVE INGREDIENT | 0X9PA28K43 | VISUDYNE (VERTEPORFIN FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 4 | |
| VERTEPORFIN | ACTIVE MOIETY | 0X9PA28K43 | VISUDYNE (VERTEPORFIN FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 4 | |
| ASCORBYL PALMITATE | INACTIVE INGREDIENT | QN83US2B0N | VISUDYNE (VERTEPORFIN FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 4 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | VISUDYNE (VERTEPORFIN FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 4 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | VISUDYNE (VERTEPORFIN FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0187-5600 | VISUDYNE (VERTEPORFIN FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAUSCH HEALTH US LLC] | 13 | Current NDC, Legacy NDC, 1 package rows | 20220506_952f4c80-50b1-4308-9ee6-311ffefb13df.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0187-5600-15 | 00187560015 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0187-5600-15) | 2000-04-12 | 2027-12-01 | No | No | Current |