ZYNLONTA
- Product NDC
- 79952-110
- 11-digit product format
- 799520110
- Labeler code
- 79952
- Product ID
- 79952-110_42deedca-b1fa-45ec-aea7-69ce6ecb8c96
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- loncastuximab tesirine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- ADC Therapeutics America, Inc.
- Application
- BLA761196
- Marketing category
- BLA
- Marketing start
- 2021-04-30
- Substance
- LONCASTUXIMAB TESIRINE
- Active strength
- 10 mg/2mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZYNLONTA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LONCASTUXIMAB TESIRINE | 10 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7K5O7P6QIU |
| Rxcui | 2540969, 2540974 |
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 |
|---|
| 79952-110-01 | ZYNLONTA | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 2 | | 14 |
| 79952-110-01 | ZYNLONTA | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 79952-110 | ZYNLONTA (LONCASTUXIMAB TESIRINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ADC THERAPEUTICS AMERICA, INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240716_af54af12-3edf-4301-8bc5-0446bc813c1d.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 |
|---|
| 79952-110-01 | 79952011001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (79952-110-01) / 2 mL in 1 VIAL, SINGLE-DOSE | 2021-04-30 | 0000-00-00 | No | No | Current |