Home NDC 0078-0673 HYCAMTIN
Product NDC 0078-0673
11-digit product format 000780673
Labeler code 0078
Product ID 0078-0673_bf2754e4-bfee-452c-a095-3038c45d56c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name topotecan
Dosage form CAPSULE
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA020981
Marketing category NDA
Marketing start 2017-02-24
Marketing end 0000-00-00
Substance TOPOTECAN HYDROCHLORIDE
Active strength 1 mg/1
Pharmacologic classes Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020981-001 HYCAMTIN TOPOTECAN HYDROCHLORIDE EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 N020981-002 HYCAMTIN TOPOTECAN HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11
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 3 · 84 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 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 2 · 70 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020981-002 8158645 2024-12-10 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020981-002 8158645 2024-12-10 Drug product 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020981-002 8158645 2024-12-10 Drug product 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020981-002 8158645 2024-12-10 Drug product d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020981-002 8158645 2024-12-10 Drug product d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020981-002 8158645 2024-12-10 Drug product 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020981-002 8158645 2024-12-10 Drug product 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020981-002 8158645 2024-12-10 Drug product 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020981-002 8158645 2024-12-10 Drug product 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020981-002 8158645 2024-12-10 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020981-002 8158645 2024-12-10 Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020981-002 8158645 2024-12-10 Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020981-002 8158645 2024-12-10 Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020981-002 8158645 2024-12-10 Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020981-002 8158645 2024-12-10 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020981-002 8158645 2024-12-10 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020981-002 8158645 2024-12-10 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020981-002 8158645 2024-12-10 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N020981-002 8158645 2024-12-10 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020981-001 8158645 2024-12-10 Drug product 2012-05-11 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020981-002 8158645 2024-12-10 Drug product 3f01610625f2…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0673 HYCAMTIN (TOPOTECAN) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION] 8 Legacy NDC 20220709_aa0815bb-8916-4c2c-9201-b04eb78e91fa.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 Sandoz Inc b23b46f5-c276-47f5-8bbd-940680b3f579 2023-09-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020981 application number: NDA020981
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0673-01 00078067301 10 CAPSULE in 1 BOTTLE (0078-0673-01) 10 capsule 2017-02-24 0000-00-00 No No Current