Home NDC 0078-0674 HYCAMTIN
Product NDC 0078-0674
11-digit product format 000780674
Labeler code 0078
Product ID 0078-0674_e6e4f66b-e398-44d3-a832-e5a809f3e861
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name topotecan hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Novartis Pharmaceuticals Corporation
Application NDA020671
Marketing category NDA
Marketing start 2016-12-21
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 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 N020671-001 HYCAMTIN TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020671-001 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 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020671-001 HYCAMTIN EQ 4MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-05-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base HYCAMTIN
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 637550 Internal RxNorm lookup 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 0078-0674-61 HYCAMTIN 4 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 4 8 0078-0674-61 HYCAMTIN 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0674 HYCAMTIN (TOPOTECAN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] 8 Current NDC, Legacy NDC, 2 package rows 20220709_eeee060c-a9ec-423e-a374-8484009f8524.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 HYCAMTIN TOPOTECAN HYDROCHLORIDE Novartis Pharmaceuticals Corporation eeee060c-a9ec-423e-a374-8484009f8524 2022-07-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020671 application number: NDA020671 ndc (product): 0078-0674
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 0078-0674-61 00078067461 1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0674-61) / 4 mL in 1 VIAL, SINGLE-DOSE 2016-12-21 0000-00-00 No No Current