LIBTAYO
- Product NDC
- 61755-008
- 11-digit product format
- 617550008
- Labeler code
- 61755
- Product ID
- 61755-008_541a4e20-6a70-4164-8504-413f0d654042
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cemiplimab-rwlc
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Regeneron Pharmaceuticals, Inc.
- Application
- BLA761097
- Marketing category
- BLA
- Marketing start
- 2018-09-28
- Substance
- CEMIPLIMAB
- Active strength
- 50 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LIBTAYO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CEMIPLIMAB | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6QVL057INT |
| Rxcui | 2058830, 2058835 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61755-008-01 | LIBTAYO | 7 mL in 1 VIAL, SINGLE-USE | INJECTION | 7 | | 23 |
| 61755-008-01 | LIBTAYO | 1 in 1 CARTON | INJECTION | 1 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61755-008 | LIBTAYO (CEMIPLIMAB-RWLC) INJECTION [REGENERON PHARMACEUTICALS, INC.] | 20 | Current NDC, Legacy NDC, 2 package rows | 20240608_4347ae1f-d397-4f18-8b70-03897e1c054a.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 |
|---|
| 61755-008-01 | 61755000801 | 1 VIAL, SINGLE-USE in 1 CARTON (61755-008-01) / 7 mL in 1 VIAL, SINGLE-USE | 2018-09-28 | 0000-00-00 | No | No | Current |