Home NDC 0409-0302-01 Topotecan
Product NDC 0409-0302
Requested package NDC 0409-0302-01
11-digit product format 004090302
Labeler code 0409
Product ID 0409-0302_293334d4-88f2-4ec2-9eed-20975ff65c0a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TOPOTECAN
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Hospira, Inc.
Application NDA200582
Marketing category NDA
Marketing start 2011-02-21
Substance TOPOTECAN HYDROCHLORIDE
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 43 .
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 N200582-001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N200582-001 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 · 43 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 2026-09-14 22:38:34 2026-08 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N200582-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2011-02-02 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Topotecan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOPOTECAN HYDROCHLORIDE 1 mg/mL
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 1799424 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 0409-0302-01 Topotecan 4 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 4 23 0409-0302-01 Topotecan 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOPOTECAN HYDROCHLORIDE ACTIVE INGREDIENT 956S425ZCY TOPOTECAN (TOPOTECAN HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 16 TOPOTECAN ACTIVE MOIETY 7M7YKX2N15 TOPOTECAN (TOPOTECAN HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 16 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB TOPOTECAN (TOPOTECAN HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 16 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I TOPOTECAN (TOPOTECAN HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 16 TARTARIC ACID INACTIVE INGREDIENT W4888I119H TOPOTECAN (TOPOTECAN HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 16 WATER INACTIVE INGREDIENT 059QF0KO0R TOPOTECAN (TOPOTECAN HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-0302 TOPOTECAN INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 23 Current NDC, Legacy NDC, 2 package rows 20210203_1d4e1cce-c57e-4a8b-be96-f95a2778e221.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 Marketing start Marketing end Sample Exclude flag Status 0409-0302-01 00409030201 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0302-01) / 4 mL in 1 VIAL, SINGLE-DOSE 2011-02-21 0000-00-00 No No Current