Home NDC 45963-615 Topotecan hydrochloride
Product NDC 45963-615
11-digit product format 459630615
Labeler code 45963
Product ID 45963-615_0edbf531-9ae9-4f9d-a606-f8f56768ce9d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Topotecan hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Actavis Pharma, Inc.
Application ANDA090620
Marketing category ANDA
Marketing start 2015-01-05
Substance TOPOTECAN HYDROCHLORIDE
Active strength 4 mg/4mL
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 1 .
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 A090620-001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090620-001 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 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090620-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2010-12-02 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Topotecan hydrochloride
Listing expiration 2026-12-31 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45963-615-56 Topotecan hydrochloride 4 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 4 10 45963-615-56 Topotecan hydrochloride 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOPOTECAN HYDROCHLORIDE ACTIVE INGREDIENT 956S425ZCY TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] 5 TOPOTECAN ACTIVE MOIETY 7M7YKX2N15 TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] 5 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] 5 MANNITOL INACTIVE INGREDIENT 3OWL53L36A TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] 5 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] 5 TARTARIC ACID INACTIVE INGREDIENT W4888I119H TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45963-615 TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20221122_996430c0-ee26-4ed9-82b8-a8b645becba6.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 45963-615-56 45963061556 1 VIAL in 1 CARTON (45963-615-56) / 4 mL in 1 VIAL 1 vial 2015-01-05 0000-00-00 No No Current