Home NDC 55390-370 Topotecan Hydrochloride
Product NDC 55390-370
11-digit product format 553900370
Labeler code 55390
Product ID 55390-370_654d0d44-73a6-baa4-78ec-8fa492237dab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Topotecan Hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Bedford Laboratories
Application ANDA201191
Marketing category ANDA
Marketing start 2011-04-18
Marketing end 0000-00-00
Substance TOPOTECAN HYDROCHLORIDE
Active strength 4 mg/4mL
Pharmacologic classes Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 30 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 55390-370-10 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 55390-370-10 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 55390-370-10 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 55390-370-10 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 55390-370-10 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 55390-370-10 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 55390-370-10 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 55390-370-10 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 55390-370-10 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 55390-370-10 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 55390-370-10 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 55390-370-10 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 55390-370-10 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 55390-370-10 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 55390-370-10 1332a3947898…d4bfe170f9cd…
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 A201191-001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201191-001 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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201191-001 TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP 2011-03-09 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55390-370-10 Topotecan Hydrochloride 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 5 55390-370-10 Topotecan Hydrochloride 4 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 4 5
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 [BEDFORD LABORATORIES ] 3 Topotecan ACTIVE MOIETY 7M7YKX2N15 TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ] 3 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ] 3 Mannitol INACTIVE INGREDIENT 3OWL53L36A TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ] 3 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ] 3 Tartaric Acid INACTIVE INGREDIENT W4888I119H TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55390-370 TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ] 5 Legacy NDC, 2 package rows 20181211_a439bf07-53db-0352-846a-99d9da772f9b.zip
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 55390-370-10 55390037010 1 VIAL in 1 CARTON (55390-370-10) > 4 mL in 1 VIAL 1 vial 2020-12-01 0000-00-00 No No Current