Topotecan

Product NDC: 66758-051
11-digit product format: 667580051
Labeler code: 66758
Product ID: 66758-051_6bc88223-4de9-4ff7-b59f-e479c1fce600
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topotecan
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Sandoz Inc
Application: NDA200199
Marketing category: NDA
Marketing start: 2011-02-25
Marketing end: 0000-00-00
Substance: TOPOTECAN HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66758-051		D	Discontinued by firm		2026-08-17
excluded package	package	66758-051	66758-051-05	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66758-051-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66758-051-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66758-051-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66758-051-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66758-051-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66758-051-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66758-051-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66758-051-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66758-051-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66758-051-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66758-051-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66758-051-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N200199-001	TOPOTECAN	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25
N200199-002	TOPOTECAN	TOPOTECAN HYDROCHLORIDE	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25
N200199-003	TOPOTECAN	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N200199-001	TOPOTECAN	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200199-002	TOPOTECAN	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200199-003	TOPOTECAN	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200199-001	TOPOTECAN	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200199-002	TOPOTECAN	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200199-003	TOPOTECAN	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200199-001	TOPOTECAN	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200199-002	TOPOTECAN	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200199-003	TOPOTECAN	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200199-001	TOPOTECAN	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200199-002	TOPOTECAN	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200199-003	TOPOTECAN	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200199-001	TOPOTECAN	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200199-002	TOPOTECAN	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200199-003	TOPOTECAN	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200199-001	TOPOTECAN	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200199-002	TOPOTECAN	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200199-003	TOPOTECAN	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200199-001	TOPOTECAN	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200199-002	TOPOTECAN	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200199-003	TOPOTECAN	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200199-001	TOPOTECAN	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200199-002	TOPOTECAN	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200199-003	TOPOTECAN	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200199-001	TOPOTECAN	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200199-002	TOPOTECAN	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200199-003	TOPOTECAN	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200199-001	TOPOTECAN	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200199-002	TOPOTECAN	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200199-003	TOPOTECAN	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200199-001	TOPOTECAN	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200199-002	TOPOTECAN	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200199-003	TOPOTECAN	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200199-001	TOPOTECAN	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200199-002	TOPOTECAN	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200199-003	TOPOTECAN	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200199-001	TOPOTECAN	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200199-002	TOPOTECAN	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200199-003	TOPOTECAN	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200199-001	TOPOTECAN	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2011-02-25	`1e350fbaab3a…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
66758-051-01	2019-11-19	These highlights do not include all the information needed to use Topotecan Injection safely and effectively. See full prescribing information for Topotecan Injection. Must be diluted before intravenous infusion Initial U.S. Approval: 1996
66758-051-03	2019-11-19	These highlights do not include all the information needed to use Topotecan Injection safely and effectively. See full prescribing information for Topotecan Injection. Must be diluted before intravenous infusion Initial U.S. Approval: 1996
66758-051-05	2019-11-19	These highlights do not include all the information needed to use Topotecan Injection safely and effectively. See full prescribing information for Topotecan Injection. Must be diluted before intravenous infusion Initial U.S. Approval: 1996
66758-051-01	2019-10-29	These highlights do not include all the information needed to use Topotecan Injection safely and effectively. See full prescribing information for Topotecan Injection. Must be diluted before intravenous infusion Initial U.S. Approval: 1996
66758-051-03	2019-10-29	These highlights do not include all the information needed to use Topotecan Injection safely and effectively. See full prescribing information for Topotecan Injection. Must be diluted before intravenous infusion Initial U.S. Approval: 1996
66758-051-05	2019-10-29	These highlights do not include all the information needed to use Topotecan Injection safely and effectively. See full prescribing information for Topotecan Injection. Must be diluted before intravenous infusion Initial U.S. Approval: 1996

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOPOTECAN HYDROCHLORIDE	ACTIVE INGREDIENT	956S425ZCY	TOPOTECAN INJECTION [SANDOZ INC]	1
TOPOTECAN	ACTIVE MOIETY	7M7YKX2N15	TOPOTECAN INJECTION [SANDOZ INC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	TOPOTECAN INJECTION [SANDOZ INC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TOPOTECAN INJECTION [SANDOZ INC]	1
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	TOPOTECAN INJECTION [SANDOZ INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPOTECAN INJECTION [SANDOZ INC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
956S425ZCY	TOPOTECAN HYDROCHLORIDE	119413-54-6	TOPOTECAN HYDROCHLORIDE
7M7YKX2N15	TOPOTECAN	123948-87-8	Topotecan