Home NDC 66758-101 HYCAMTIN
Product NDC 66758-101
11-digit product format 667580101
Labeler code 66758
Product ID 66758-101_b23b46f5-c276-47f5-8bbd-940680b3f579
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name topotecan
Dosage form CAPSULE
Route ORAL
Labeler Sandoz Inc
Application NDA020981
Marketing category NDA
Marketing start 2017-07-07
Substance TOPOTECAN HYDROCHLORIDE
Active strength .25 mg/1
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 · 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.
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 2026-08-01 22:54:32 2026-06 N020981-001 HYCAMTIN EQ 0.25MG BASE CAPSULE / ORAL RLD 2007-10-11 a50c72e98297…2026-08-01 22:54:32 2026-06 N020981-002 HYCAMTIN EQ 1MG BASE CAPSULE / ORAL RLD, RS 2007-10-11 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base HYCAMTIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOPOTECAN HYDROCHLORIDE .25 mg/1
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 747193 Internal RxNorm lookup 747195 Internal RxNorm lookup 748738 Internal RxNorm lookup 748740 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 66758-101-11 HYCAMTIN 10 in 1 BOTTLE CAPSULE 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66758-101 HYCAMTIN (TOPOTECAN) CAPSULE [SANDOZ INC] 1 Current NDC, 1 package rows 20241031_b23b46f5-c276-47f5-8bbd-940680b3f579.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 66758-101-11 66758010111 10 CAPSULE in 1 BOTTLE (66758-101-11) 10 capsule 2025-01-06 No No Current