Antibodies, Monoclonal [CS] - M0001357

Name: Table of NDC products with antibodies, monoclonal
Creator: U.S. Food & Drug Administration
License: https://creativecommons.org/licenses/by-nc-sa/4.0/

Pharmacologic Class Information

Pharmacologic Code	M0001357
Pharmacologic Name	Antibodies, Monoclonal
Pharmacologic Uses	CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody CD20-directed cytolytic antibody CD38-directed cytolytic antibody epidermal growth factor receptor (EGFR) antagonist interleukin-17 receptor A (IL-17RA) antagonist interleukin-4 receptor alpha antagonist PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor programmed death ligand-1 (PD-L1) blocking antibody programmed death receptor-1 (PD-1)-blocking antibody SLAMF7-directed immunostimulatory antibody tumor necrosis factor (TNF) blocker
Pharmacologic Concept	Chemical Structure - [CS]
Pharmacologic Concept Description	This concept refers to the chemical structure and classification containing chemicals or other drug ingredients, organized into a chemical structure classification hierarchy.

NDC Products with Antibodies, Monoclonal

The table contains 80 products whose active ingredient are classified under the same pharmacologic class Antibodies, Monoclonal [CS].

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
0003-2291	Empliciti	Non-Proprietary Name: Elotuzumab	Injection, Powder, Lyophilized, For Solution	Intravenous	E.r. Squibb & Sons, L.l.c.	ACTIVE
0003-4522	Empliciti	Non-Proprietary Name: Elotuzumab	Injection, Powder, Lyophilized, For Solution	Intravenous	E.r. Squibb & Sons, L.l.c.	ACTIVE
0024-0654	Sarclisa	Non-Proprietary Name: Isatuximab	Injection, Solution, Concentrate	Intravenous	Sanofi-aventis U.s. Llc	ACTIVE
0024-0656	Sarclisa	Non-Proprietary Name: Isatuximab	Injection, Solution, Concentrate	Intravenous	Sanofi-aventis U.s. Llc	ACTIVE
0024-5901	Praluent	Non-Proprietary Name: Alirocumab	Injection, Solution	Subcutaneous	Sanofi-aventis U.s. Llc	ACTIVE
0024-5902	Praluent	Non-Proprietary Name: Alirocumab	Injection, Solution	Subcutaneous	Sanofi-aventis U.s. Llc	ACTIVE
0024-5903	Praluent	Non-Proprietary Name: Alirocumab	Injection, Solution	Subcutaneous	Sanofi-aventis U.s. Llc	ACTIVE
0024-5904	Praluent	Non-Proprietary Name: Alirocumab	Injection, Solution	Subcutaneous	Sanofi-aventis U.s. Llc	ACTIVE
0024-5911	Dupixent	Non-Proprietary Name: Dupilumab	Injection, Solution	Subcutaneous	Sanofi-aventis U.s. Llc	ACTIVE
0024-5914	Dupixent	Non-Proprietary Name: Dupilumab	Injection, Solution	Subcutaneous	Sanofi-aventis U.s. Llc	ACTIVE
0024-5915	Dupixent	Non-Proprietary Name: Dupilumab	Injection, Solution	Subcutaneous	Sanofi-aventis U.s. Llc	ACTIVE
0024-5918	Dupixent	Non-Proprietary Name: Dupilumab	Injection, Solution	Subcutaneous	Sanofi-aventis U.s. Llc	ACTIVE
0024-5919	Dupixent	Non-Proprietary Name: Dupilumab	Injection, Solution	Subcutaneous	Sanofi-aventis U.s. Llc	ACTIVE
0187-0004	Siliq	Non-Proprietary Name: Brodalumab	Injection	Subcutaneous	Bausch Health Us Llc	ACTIVE
0310-4500	Imfinzi	Non-Proprietary Name: Durvalumab	Injection, Solution	Intravenous	Astrazeneca Pharmaceuticals Lp	ACTIVE
0310-4611	Imfinzi	Non-Proprietary Name: Durvalumab	Injection, Solution	Intravenous	Astrazeneca Pharmaceuticals Lp	ACTIVE
42747-761	Poteligeo	Non-Proprietary Name: Mogamulizumab-kpkc	Injection	Intravenous	Kyowa Kirin, Inc.	ACTIVE
44087-3535	Bavencio	Non-Proprietary Name: Avelumab	Injection, Solution, Concentrate	Intravenous	Emd Serono, Inc.	ACTIVE
50090-6411	Amjevita	Non-Proprietary Name: Adalimumab-atto	Injection	Subcutaneous	A-s Medication Solutions	ACTIVE
50090-6428	Amjevita	Non-Proprietary Name: Adalimumab-atto	Injection	Subcutaneous	A-s Medication Solutions	ACTIVE
50090-6704	Hadlima	Non-Proprietary Name: Adalimumab-bwwd	Solution	Subcutaneous	A-s Medication Solutions	ACTIVE
50090-6705	Hadlima	Non-Proprietary Name: Adalimumab-bwwd	Solution	Subcutaneous	A-s Medication Solutions	ACTIVE
50090-6706	Hadlima	Non-Proprietary Name: Adalimumab-bwwd	Solution	Subcutaneous	A-s Medication Solutions	ACTIVE
50090-6707	Hadlima	Non-Proprietary Name: Adalimumab-bwwd	Solution	Subcutaneous	A-s Medication Solutions	ACTIVE
50242-150	Ocrevus	Non-Proprietary Name: Ocrelizumab	Injection	Intravenous	Genentech, Inc.	ACTIVE
50242-917	Tecentriq	Non-Proprietary Name: Atezolizumab	Injection, Solution	Intravenous	Genentech, Inc.	ACTIVE
50242-918	Tecentriq	Non-Proprietary Name: Atezolizumab	Injection, Solution	Intravenous	Genentech, Inc.	ACTIVE
55513-399	Amjevita	Non-Proprietary Name: Adalimumab-atto	Injection	Subcutaneous	Amgen Inc	ACTIVE
55513-400	Amjevita	Non-Proprietary Name: Adalimumab-atto	Injection	Subcutaneous	Amgen Inc	ACTIVE
55513-410	Amjevita	Non-Proprietary Name: Adalimumab-atto	Injection	Subcutaneous	Amgen Inc	ACTIVE
55513-411	Amjevita	Non-Proprietary Name: Adalimumab-atto	Injection	Subcutaneous	Amgen Inc	ACTIVE
55513-413	Amjevita	Non-Proprietary Name: Adalimumab-atto	Injection	Subcutaneous	Amgen Inc	ACTIVE
55513-479	Amjevita	Non-Proprietary Name: Adalimumab-atto	Injection	Subcutaneous	Amgen Inc	ACTIVE
55513-480	Amjevita	Non-Proprietary Name: Adalimumab-atto	Injection	Subcutaneous	Amgen Inc	ACTIVE
55513-481	Amjevita	Non-Proprietary Name: Adalimumab-atto	Injection	Subcutaneous	Amgen Inc	ACTIVE
55513-482	Amjevita	Non-Proprietary Name: Adalimumab-atto	Injection	Subcutaneous	Amgen Inc	ACTIVE
55513-750	Repatha	Non-Proprietary Name: Evolocumab	Injection, Solution	Subcutaneous	Amgen Inc	ACTIVE
55513-760	Repatha	Non-Proprietary Name: Evolocumab	Injection, Solution	Subcutaneous	Amgen Inc	ACTIVE
55513-954	Vectibix	Non-Proprietary Name: Panitumumab	Solution	Intravenous	Amgen Inc	ACTIVE
55513-956	Vectibix	Non-Proprietary Name: Panitumumab	Solution	Intravenous	Amgen Inc	ACTIVE
57894-502	Darzalex	Non-Proprietary Name: Daratumumab	Injection, Solution, Concentrate	Intravenous	Janssen Biotech, Inc.	ACTIVE
57894-503	Darzalex Faspro	Non-Proprietary Name: Daratumumab And Hyaluronidase-fihj (human Recombinant)	Injection	Subcutaneous	Janssen Biotech, Inc.	ACTIVE
57894-505	Darzalex Iv	Non-Proprietary Name: Daratumumab	Injection, Solution, Concentrate	Intravenous	Janssen Biotech, Inc.	ACTIVE
61314-327	Adalimumab	Non-Proprietary Name: Adalimumab-adaz	Injection, Solution	Subcutaneous	Sandoz Inc.	ACTIVE
61314-454	Hyrimoz	Non-Proprietary Name: Adalimumab-adaz	Injection, Solution	Subcutaneous	Sandoz Inc	ACTIVE
61314-473	Hyrimoz	Non-Proprietary Name: Adalimumab-adaz	Injection, Solution	Subcutaneous	Sandoz Inc	ACTIVE
61314-476	Hyrimoz	Non-Proprietary Name: Adalimumab-adaz	Injection, Solution	Subcutaneous	Sandoz Inc	ACTIVE
61314-509	Hyrimoz	Non-Proprietary Name: Adalimumab-adaz	Injection, Solution	Subcutaneous	Sandoz Inc	ACTIVE
61755-020	Praluent	Non-Proprietary Name: Alirocumab	Injection, Solution	Subcutaneous	Regeneron Pharmaceuticals, Inc.	ACTIVE
61755-021	Praluent	Non-Proprietary Name: Alirocumab	Injection, Solution	Subcutaneous	Regeneron Pharmaceuticals, Inc.	ACTIVE
65219-554	Idacio	Non-Proprietary Name: Adalimumab	Injection, Solution	Subcutaneous	Fresenius Kabi Usa, Llc	ACTIVE
65219-556	Idacio	Non-Proprietary Name: Adalimumab	Injection, Solution	Subcutaneous	Fresenius Kabi Usa, Llc	ACTIVE
66658-230	Synagis	Non-Proprietary Name: Palivizumab	Injection, Solution	Intramuscular	Swedish Orphan Biovitrum Ab (publ)	ACTIVE
66658-231	Synagis	Non-Proprietary Name: Palivizumab	Injection, Solution	Intramuscular	Swedish Orphan Biovitrum Ab (publ)	ACTIVE
70114-210	Yusimry	Non-Proprietary Name: Adalimumab-aqvh	Injection, Solution	Subcutaneous	Coherus Biosciences Inc	ACTIVE
70114-220	Yusimry	Non-Proprietary Name: Adalimumab-aqvh	Injection, Solution	Subcutaneous	Coherus Biosciences Inc	ACTIVE
72511-400	Amjevita	Non-Proprietary Name: Adalimumab-atto	Injection	Subcutaneous	Amgen Usa Inc.	ACTIVE
72511-482	Amjevita	Non-Proprietary Name: Adalimumab-atto	Injection	Subcutaneous	Amgen Usa Inc.	ACTIVE
72511-750	Repatha	Non-Proprietary Name: Evolocumab	Injection, Solution	Subcutaneous	Amgen Usa Inc.	ACTIVE
72511-760	Repatha	Non-Proprietary Name: Evolocumab	Injection, Solution	Subcutaneous	Amgen Usa Inc.	ACTIVE
72606-022	Adalimumab	Non-Proprietary Name: Adalimumab-aaty	Injection	Subcutaneous	Celltrion Usa, Inc.	ACTIVE
72606-023	Yuflyma	Non-Proprietary Name: Adalimumab	Injection	Subcutaneous	Celltrion Usa, Inc.	ACTIVE
72606-024	Yuflyma	Non-Proprietary Name: Adalimumab	Injection	Subcutaneous	Celltrion Usa, Inc.	ACTIVE
72606-030	Yuflyma	Non-Proprietary Name: Adalimumab	Injection	Subcutaneous	Celltrion Usa, Inc.	ACTIVE
72606-040	Adalimumab	Non-Proprietary Name: Adalimumab-aaty	Injection	Subcutaneous	Celltrion Usa, Inc.	ACTIVE
72606-041	Adalimumab	Non-Proprietary Name: Adalimumab-aaty	Injection	Subcutaneous	Celltrion Usa, Inc.	ACTIVE
72733-5901	Praluent	Non-Proprietary Name: Alirocumab	Injection, Solution	Subcutaneous	Sanofi Us Corporation	ACTIVE
72733-5902	Praluent	Non-Proprietary Name: Alirocumab	Injection, Solution	Subcutaneous	Sanofi Us Corporation	ACTIVE
78206-183	Hadlima	Non-Proprietary Name: Adalimumab-bwwd	Solution	Subcutaneous	Organon Llc	ACTIVE
78206-184	Hadlima	Non-Proprietary Name: Adalimumab-bwwd	Solution	Subcutaneous	Organon Llc	ACTIVE
78206-185	Hadlima	Non-Proprietary Name: Adalimumab-bwwd	Solution	Subcutaneous	Organon Llc	ACTIVE
78206-186	Hadlima	Non-Proprietary Name: Adalimumab-bwwd	Solution	Subcutaneous	Organon Llc	ACTIVE
78206-187	Hadlima	Non-Proprietary Name: Adalimumab-bwwd	Solution	Subcutaneous	Organon Llc	ACTIVE
83457-100	Hyrimoz	Non-Proprietary Name: Adalimumab-adaz	Injection, Solution	Subcutaneous	Cordavis Limited	ACTIVE
83457-101	Hyrimoz	Non-Proprietary Name: Adalimumab-adaz	Injection, Solution	Subcutaneous	Cordavis Limited	ACTIVE
83457-102	Hyrimoz	Non-Proprietary Name: Adalimumab-adaz	Injection, Solution	Subcutaneous	Cordavis Limited	ACTIVE
83457-103	Hyrimoz	Non-Proprietary Name: Adalimumab-adaz	Injection, Solution	Subcutaneous	Cordavis Limited	ACTIVE
83457-107	Hyrimoz	Non-Proprietary Name: Adalimumab-adaz	Injection, Solution	Subcutaneous	Cordavis Limited	ACTIVE
83457-108	Hyrimoz	Non-Proprietary Name: Adalimumab-adaz	Injection, Solution	Subcutaneous	Cordavis Limited	ACTIVE
83457-113	Hyrimoz	Non-Proprietary Name: Adalimumab-adaz	Injection, Solution	Subcutaneous	Cordavis Limited	ACTIVE