NDC 0003-4522

EMPLICITI

Elotuzumab

EMPLICITI is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by E.r. Squibb & Sons, L.l.c.. The primary component is Elotuzumab.

• Product ID: 0003-4522_110f3d22-eae5-40ed-8818-3930a32f2c04
• NDC: 0003-4522
• Product Type: Human Prescription Drug
• Proprietary Name: EMPLICITI
• Generic Name: Elotuzumab
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-11-30
• Marketing Category: BLA / BLA
• Application Number: BLA761035
• Labeler Name: E.R. Squibb & Sons, L.L.C.
• Substance Name: ELOTUZUMAB
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Antibodies, Monoclonal [CS], SLAMF7-directed Antibody Interactions [MoA], SLAMF7-directed Immunostimulatory Antibody [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0003-4522-11

1 VIAL, SINGLE-USE in 1 CARTON (0003-4522-11) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2015-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0003-4522-11 [00003452211]

EMPLICITI INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA761035
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-11-30

Drug Details

Active Ingredients

Ingredient	Strength
ELOTUZUMAB	400 mg/1

OpenFDA Data

• SPL SET ID: 80686b7e-f6f4-4154-b5c0-c846425e2d91
• Manufacturer:
  • E.R. Squibb & Sons, L.L.C.
• UNII:
  • 1351PE5UGS
• RxNorm Concept Unique ID - RxCUI:
  • 1726115
  • 1726117
  • 1726119
  • 1726110

Pharmacological Class

• SLAMF7-directed Immunostimulatory Antibody [EPC]
• SLAMF7-directed Antibody Interactions [MoA]
• Antibodies
• Monoclonal [CS]

NDC Crossover Matching brand name "EMPLICITI" or generic name "Elotuzumab"

NDC	Brand Name	Generic Name
0003-2291	EMPLICITI	elotuzumab
0003-4522	EMPLICITI	elotuzumab