Topotecan

Product NDC: 16729-243
11-digit product format: 167290243
Labeler code: 16729
Product ID: 16729-243_46296320-1014-df71-e063-6294a90ac862
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topotecan
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Accord Healthcare Inc.
Application: ANDA204406
Marketing category: ANDA
Marketing start: 2020-07-08
Substance: TOPOTECAN
Active strength: 1 mg/mL
Pharmacologic classes: Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204406-001	TOPOTECAN HYDROCHLORIDE	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS			2017-07-06
A204406-002	TOPOTECAN HYDROCHLORIDE	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2017-07-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A204406-002	AP

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204406-001	TOPOTECAN HYDROCHLORIDE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS		2017-07-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204406-002	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2017-07-06	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204406-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204406-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204406-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204406-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204406-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204406-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204406-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204406-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204406-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204406-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204406-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204406-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204406-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204406-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204406-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204406-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204406-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204406-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204406-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204406-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204406-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204406-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204406-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204406-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204406-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204406-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204406-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204406-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204406-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204406-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204406-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204406-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204406-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204406-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204406-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204406-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204406-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204406-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204406-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204406-002	AP	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Topotecan
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOPOTECAN	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7M7YKX2N15	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
637549	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7636bc1e-77b6-46ad-9df0-c8bb1c5e503f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
cbf6bf79-4ea9-419f-b7df-eefa780730bf	Product name	2	20180125
19c78384-80c8-23c8-a4e6-c197ed91c59e	Product name	1	20140508
302dcbc5-1902-d63c-93ac-bac5e14c2822	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16729-243-30	Topotecan	1 in 1 CARTON	INJECTION	1	8
16729-243-30	Topotecan	1 mL in 1 VIAL, MULTI-DOSE	INJECTION	1	8
16729-243-31	Topotecan	4 mL in 1 VIAL, MULTI-DOSE	INJECTION	4	8
16729-243-31	Topotecan	1 in 1 CARTON	INJECTION	1	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-243-31	ML - Milliliter	16729-243	52266a3b-45b8-4077-8c1e-6c3c8c059a5c	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-243	TOPOTECAN INJECTION [ACCORD HEALTHCARE INC.]	7	Current NDC, Legacy NDC, 4 package rows	20240216_7636bc1e-77b6-46ad-9df0-c8bb1c5e503f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topotecan	TOPOTECAN	Accord Healthcare Inc.	7636bc1e-77b6-46ad-9df0-c8bb1c5e503f	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204406 application number: ANDA204406 ndc (product): 16729-243

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7M7YKX2N15	TOPOTECAN	123948-87-8	TOPOTECAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
637549	topotecan 1 MG/ML Injectable Solution	PSN	7636bc1e-77b6-46ad-9df0-c8bb1c5e503f	8
637549	topotecan 1 MG/ML Injectable Solution	SCD	7636bc1e-77b6-46ad-9df0-c8bb1c5e503f	8
637549	topotecan (as topotecan hydrochloride) 1 MG/ML Injectable Solution	SY	7636bc1e-77b6-46ad-9df0-c8bb1c5e503f	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-243-30	16729024330	1 in 1 CARTON					Historical
16729-243-31	16729024331	1 VIAL, MULTI-DOSE in 1 CARTON (16729-243-31) / 4 mL in 1 VIAL, MULTI-DOSE	2020-07-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topotecan	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2025-12-17	HUMAN PRESCRIPTION DRUG LABEL	8