Topoisomerase Inhibitor [EPC] - N0000175609

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

Pharmacologic Class Information

Pharmacologic Code	N0000175609
Pharmacologic Name	Topoisomerase Inhibitor
Pharmacologic Uses	topoisomerase inhibitor
Pharmacologic Concept	Established Pharmacologic Classes - [EPC]
Pharmacologic Concept Description	An established pharmacologic class is a term or phrase that is scientifically valid and clinically meaningful according to the following definitions: A scientifically valid pharmacologic class is supported by documented and submitted empiric evidence showing that the drug's pharmacologic class is known, not theoretical, and relevant and specific to the indication. A clinically meaningful pharmacologic class term or phrase enhances the ability of professionals to understand physiologic effects related to the indication or to anticipate undesirable effects that may be associated with the drug or pharmacologic class.

NDC Products with Topoisomerase Inhibitor

The table contains 59 products whose active ingredient are classified under the same pharmacologic class Topoisomerase Inhibitor [EPC].

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
0009-0082	Camptosar	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Solution	Intravenous	Pharmacia & Upjohn Company Llc	ACTIVE
0009-0112	Camptosar	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Solution	Intravenous	Pharmacia & Upjohn Company Llc	ACTIVE
0009-7529	Camptosar	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Solution	Intravenous	Pharmacia & Upjohn Company Llc	ACTIVE
0078-0672	Hycamtin	Non-Proprietary Name: Topotecan	Capsule	Oral	Novartis Pharmaceuticals Corporation	ACTIVE
0078-0673	Hycamtin	Non-Proprietary Name: Topotecan	Capsule	Oral	Novartis Pharmaceuticals Corporation	ACTIVE
0078-0674	Hycamtin	Non-Proprietary Name: Topotecan Hydrochloride	Injection, Powder, Lyophilized, For Solution	Intravenous	Novartis Pharmaceuticals Corporation	ACTIVE
0143-9376	Etoposide	Non-Proprietary Name: Etoposide	Injection	Intravenous	Hikma Pharmaceuticals Usa Inc.	ACTIVE
0143-9510	Etoposide	Non-Proprietary Name: Etoposide	Injection	Intravenous	Hikma Pharmaceuticals Usa Inc.	ACTIVE
0143-9511	Etoposide	Non-Proprietary Name: Etoposide	Injection	Intravenous	Hikma Pharmaceuticals Usa Inc.	ACTIVE
0143-9512	Etoposide	Non-Proprietary Name: Etoposide	Injection	Intravenous	Hikma Pharmaceuticals Usa Inc.	ACTIVE
0143-9583	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection	Intravenous	Hikma Pharmaceuticals Usa Inc.	ACTIVE
0143-9701	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection	Intravenous	Hikma Pharmaceuticals Usa Inc.	ACTIVE
0143-9702	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection	Intravenous	Hikma Pharmaceuticals Usa Inc.	ACTIVE
0378-3266	Etoposide	Non-Proprietary Name: Etoposide	Capsule	Oral	Mylan Pharmaceuticals Inc.	ACTIVE
0409-0302	Topotecan	Non-Proprietary Name:			Hospira, Inc.
0409-0302	Topotecan	Non-Proprietary Name: Topotecan	Injection, Solution, Concentrate	Intravenous	Hospira, Inc.	ACTIVE
15054-0043	Onivyde	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Powder, For Solution	Intravenous	Ipsen Biopharmaceuticals, Inc.	ACTIVE
16714-027	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection	Intravenous	Northstar Rx Llc	ACTIVE
16714-131	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection	Intravenous	Northstar Rx Llc	ACTIVE
16729-114	Etoposide	Non-Proprietary Name: Etoposide	Injection	Intravenous	Accord Healthcare Inc.	ACTIVE
16729-151	Topotecan Hydrochloride	Non-Proprietary Name: Topotecan Hydrochloride	Injection, Powder, Lyophilized, For Solution	Intravenous	Accord Healthcare, Inc.	ACTIVE
16729-243	Topotecan	Non-Proprietary Name: Topotecan	Injection	Intravenous	Accord Healthcare Inc.	ACTIVE
25021-230	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Solution	Intravenous	Sagent Pharmaceuticals	ACTIVE
45963-614	Irinotecan Hydrochloride	Non-Proprietary Name:			Actavis Pharma, Inc.
45963-614	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Solution	Intravenous	Actavis Pharma, Inc.	ACTIVE
45963-615	Topotecan Hydrochloride	Non-Proprietary Name: Topotecan Hydrochloride	Injection, Powder, Lyophilized, For Solution	Intravenous	Actavis Pharma, Inc.	ACTIVE
50742-401	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection	Intravenous	Ingenus Pharmaceuticals, Llc	ACTIVE
50742-402	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection	Intravenous	Ingenus Pharmaceuticals, Llc	ACTIVE
55150-352	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Solution	Intravenous	Eugia Us Llc	ACTIVE
55150-353	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Solution	Intravenous	Eugia Us Llc	ACTIVE
55150-354	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Solution	Intravenous	Eugia Us Llc	ACTIVE
55150-355	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Solution	Intravenous	Eugia Us Llc	ACTIVE
60505-6128	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Solution	Intravenous	Apotex Corp.	ACTIVE
60505-6272	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Solution	Intravenous	Apotex Corp.	ACTIVE
61269-410	Etopophos	Non-Proprietary Name: Etoposide Phosphate	Injection, Powder, Lyophilized, For Solution	Intravenous	H2-pharma, Llc	ACTIVE
61703-343	Mitoxantrone	Non-Proprietary Name: Mitoxantrone	Injection, Solution, Concentrate	Intravenous	Hospira, Inc.	ACTIVE
61703-349	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Solution	Intravenous	Hospira, Inc.	ACTIVE
63323-104	Etoposide	Non-Proprietary Name: Etoposide	Injection, Solution	Intravenous	Fresenius Kabi Usa, Llc	ACTIVE
63323-132	Mitoxantrone	Non-Proprietary Name: Mitoxantrone Hydrochloride	Injection, Solution	Intravenous	Fresenius Kabi Usa, Llc	ACTIVE
63323-193	Irinotecan Hydrochloride	Non-Proprietary Name:			Fresenius Kabi Usa, Llc
63323-193	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Solution	Intravenous	Fresenius Kabi Usa, Llc	ACTIVE
63323-762	Topotecan Hydrochloride	Non-Proprietary Name:			Fresenius Kabi Usa, Llc
63323-762	Topotecan Hydrochloride	Non-Proprietary Name: Topotecan Hydrochloride	Injection, Powder, Lyophilized, For Solution	Intravenous	Fresenius Kabi Usa, Llc	ACTIVE
66758-101	Hycamtin	Non-Proprietary Name: Topotecan	Capsule	Oral	Sandoz Inc	ACTIVE
66758-102	Hycamtin	Non-Proprietary Name: Topotecan	Capsule	Oral	Sandoz Inc	ACTIVE
67184-0511	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Solution	Intravenous	Qilu Pharmaceutical Co., Ltd.	ACTIVE
67184-0512	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Solution	Intravenous	Qilu Pharmaceutical Co., Ltd.	ACTIVE
67184-0513	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection, Solution	Intravenous	Qilu Pharmaceutical Co., Ltd.	ACTIVE
68001-265	Etoposide	Non-Proprietary Name: Etoposide	Injection	Intravenous	Bluepoint Laboratories	ACTIVE
68001-480	Irinotecan Hydrochloide	Non-Proprietary Name: Irinotecan Hydrochloide	Injection	Intravenous	Bluepoint Laboratories	ACTIVE
68083-381	Irinotecan Hydrochloide	Non-Proprietary Name: Irinotecan Hydrochloide	Injection	Intravenous	Gland Pharma Limited	ACTIVE
68083-382	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection	Intravenous	Gland Pharma Limited	ACTIVE
70700-169	Irinotecan Hydrochloide	Non-Proprietary Name: Irinotecan Hydrochloide	Injection	Intravenous	Xiromed Llc	ACTIVE
70700-170	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection	Intravenous	Xiromed Llc	ACTIVE
71288-175	Etoposide	Non-Proprietary Name: Etoposide	Injection, Solution, Concentrate	Intravenous	Meitheal Pharmaceuticals Inc.	ACTIVE
71288-176	Etoposide	Non-Proprietary Name: Etoposide	Injection, Solution, Concentrate	Intravenous	Meitheal Pharmaceuticals Inc.	ACTIVE
71288-177	Etoposide	Non-Proprietary Name: Etoposide	Injection, Solution, Concentrate	Intravenous	Meitheal Pharmaceuticals Inc.	ACTIVE
71288-178	Mitoxantrone	Non-Proprietary Name: Mitoxantrone	Injection, Solution, Concentrate	Intravenous	Meitheal Pharmaceuticals Inc.	ACTIVE
71288-179	Mitoxantrone	Non-Proprietary Name: Mitoxantrone	Injection, Solution, Concentrate	Intravenous	Meitheal Pharmaceuticals Inc.	ACTIVE
72485-211	Irinotecan Hydrochloride 40 mg/2 mL	Non-Proprietary Name: Irinotecan Hydrochloride	Injection	Intravenous	Armas Pharmaceuticals Inc.	ACTIVE
72485-212	Irinotecan Hydrochloride 100 mg/5 mL	Non-Proprietary Name: Irinotecan Hydrochloride	Injection	Intravenous	Armas Pharmaceuticals Inc.	ACTIVE
72485-213	Irinotecan Hydrochloride	Non-Proprietary Name: Irinotecan Hydrochloride	Injection	Intravenous	Armas Pharmaceuticals Inc.	ACTIVE