Onivyde
- Product NDC
- 15054-0043
- 11-digit product format
- 150540043
- Labeler code
- 15054
- Product ID
- 15054-0043_72b1786a-3437-4799-8214-f37b5be5607c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IRINOTECAN HYDROCHLORIDE
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Ipsen Biopharmaceuticals, Inc.
- Application
- NDA207793
- Marketing category
- NDA
- Marketing start
- 2015-10-22
- Substance
- IRINOTECAN HYDROCHLORIDE
- Active strength
- 4.3 mg/mL
- Pharmacologic classes
- Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Onivyde
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IRINOTECAN HYDROCHLORIDE | 4.3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 042LAQ1IIS |
| Rxcui | 1719772, 1719777 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 15054-0043-1 | Onivyde | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | | 9 |
| 15054-0043-1 | Onivyde | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, FOR SOLUTION | 10 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 15054-0043 | ONIVYDE (IRINOTECAN HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250305_c8b58efa-1820-48a4-b70d-62918fc4abfc.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 |
|---|
| 15054-0043-1 | 15054004301 | 1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) / 10 mL in 1 VIAL, SINGLE-DOSE | 2015-10-22 | 0000-00-00 | No | No | Current |