EMPLICITI
- Product NDC
- 0003-2291
- 11-digit product format
- 000032291
- Labeler code
- 0003
- Product ID
- 0003-2291_8441efc2-338a-4d1d-8fa1-9b9863a49ffd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- elotuzumab
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- E.R. Squibb & Sons, L.L.C.
- Application
- BLA761035
- Marketing category
- BLA
- Marketing start
- 2015-11-30
- Substance
- ELOTUZUMAB
- Active strength
- 300 mg/1
- Pharmacologic classes
- Antibodies, Monoclonal [CS], SLAMF7-directed Antibody Interactions [MoA], SLAMF7-directed Immunostimulatory Antibody [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- EMPLICITI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ELOTUZUMAB | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1351PE5UGS |
| Rxcui | 1726110, 1726115, 1726117, 1726119 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0003-2291-11 | EMPLICITI | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 13 |
| 0003-2291-11 | EMPLICITI | 1 in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0003-2291 | EMPLICITI (ELOTUZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20240628_80686b7e-f6f4-4154-b5c0-c846425e2d91.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 |
|---|
| 0003-2291-11 | 00003229111 | 1 VIAL, SINGLE-USE in 1 CARTON (0003-2291-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE | 2015-11-30 | 0000-00-00 | No | No | Current |