Topotecan Hydrochloride

Product NDC: 63323-762
11-digit product format: 633230762
Labeler code: 63323
Product ID: 63323-762_7f91362f-6b55-4518-b034-b54aa5881204
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TOPOTECAN HYDROCHLORIDE
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA091089
Marketing category: ANDA
Marketing start: 2010-11-30
Substance: TOPOTECAN HYDROCHLORIDE
Active strength: 4 mg/4mL
Pharmacologic classes: Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63323-762		D	Discontinued by firm	2026-08-17
excluded product	product	63323-762		D	Discontinued by firm	2026-08-17
excluded package	package	63323-762	63323-762-94	D	Discontinued by firm	2026-08-17
excluded package	package	63323-762	63323-762-55	D	Discontinued by firm	2026-08-17
excluded package	package	63323-762	63323-762-57	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 · 36 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	63323-762-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63323-762-57	`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	63323-762-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63323-762-57	`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	63323-762-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63323-762-57	`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	63323-762-55	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63323-762-57	`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	63323-762-55	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63323-762-57	`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	63323-762-55	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63323-762-57	`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	63323-762-55	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63323-762-57	`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	63323-762-55	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63323-762-57	`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	63323-762-55	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63323-762-57	`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	63323-762-55	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63323-762-57	`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	63323-762-55	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63323-762-57	`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	63323-762-55	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63323-762-57	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091089-001	TOPOTECAN HYDROCHLORIDE	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP		2010-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091089-001	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 2 · 42 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	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091089-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-11-29	`e64feba35796…`

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	A091089-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091089-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091089-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091089-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091089-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091089-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091089-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091089-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091089-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091089-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091089-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091089-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091089-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091089-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091089-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091089-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091089-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091089-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091089-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091089-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091089-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091089-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091089-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091089-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091089-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091089-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091089-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091089-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091089-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091089-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091089-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091089-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091089-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091089-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091089-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091089-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091089-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091089-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091089-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091089-001	AP	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Topotecan Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOPOTECAN HYDROCHLORIDE	4 mg/4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
956S425ZCY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1799416	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
b6019088-cd94-43b4-b5ce-ba20b6b8021e	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	Strength	SPL version
63323-762-10	Topotecan Hydrochloride	1 in 1 BOX	INJECTION, POWDER, LYOPHILIZED,	1		15
63323-762-10	Topotecan Hydrochloride	4 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	4		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-762-10	EA - Each	63323-762	1018eb56-e99d-4b4f-b87f-c915aecdf76b	1	2013-02-13
63323-762-17	EA - Each	63323-762	723c6eb3-565a-46be-9f37-694c0d613cdc	1	2013-02-13
63323-762-94	EA - Each	63323-762	a90264b3-9d81-424e-90c6-05d7165e2583	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOPOTECAN HYDROCHLORIDE	ACTIVE INGREDIENT	956S425ZCY	TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
TOPOTECAN	ACTIVE MOIETY	7M7YKX2N15	TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-762	TOPOTECAN HYDROCHLORIDE (TOPOTECAN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]	14	Current NDC, Legacy NDC, 2 package rows	20240724_b6019088-cd94-43b4-b5ce-ba20b6b8021e.zip
63323-762	TOPOTECAN HYDROCHLORIDE (TOPOTECAN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]	4	Current NDC, Legacy NDC	20210626_b094e6ba-7cf6-4fb8-8683-73d324650dd3.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 Hydrochloride	TOPOTECAN HYDROCHLORIDE	Fresenius Kabi USA, LLC	b6019088-cd94-43b4-b5ce-ba20b6b8021e	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091089 application number: ANDA091089 ndc (product): 63323-762

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
956S425ZCY	TOPOTECAN HYDROCHLORIDE	119413-54-6	TOPOTECAN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1799416	topotecan 4 MG Injection	PSN	b6019088-cd94-43b4-b5ce-ba20b6b8021e	15
1799416	topotecan 4 MG Injection	SCD	b6019088-cd94-43b4-b5ce-ba20b6b8021e	15
1799416	topotecan (as topotecan hydrochloride) 4 MG Injection	SY	b6019088-cd94-43b4-b5ce-ba20b6b8021e	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-762-10	63323076210	1 VIAL in 1 BOX (63323-762-10) / 4 mL in 1 VIAL	1 vial	2010-11-30	0000-00-00	No	No	Current
63323-762-94	63323076294	1 VIAL in 1 BOX (63323-762-94) > 4 mL in 1 VIAL	1 vial	2010-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topotecan Hydrochloride	Fresenius Kabi USA, LLC \| ScinoPharm Taiwan, Ltd.	2026-01-14	HUMAN PRESCRIPTION DRUG LABEL	15
Topotecan Hydrochloride	Fresenius Kabi USA, LLC	2025-11-27	HUMAN PRESCRIPTION DRUG LABEL	5