FDA.reportPublic FDA data

Topotecan

Product NDC
16729-243
11-digit product format
167290243
Labeler code
16729
Product ID
16729-243_46296320-1014-df71-e063-6294a90ac862
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topotecan
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Accord Healthcare Inc.
Application
ANDA204406
Marketing category
ANDA
Marketing start
2020-07-08
Substance
TOPOTECAN
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204406-001TOPOTECAN HYDROCHLORIDETOPOTECAN HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUS2017-07-06
A204406-002TOPOTECAN HYDROCHLORIDETOPOTECAN HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2017-07-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A204406-002AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204406-001TOPOTECAN HYDROCHLORIDEEQ 1MG BASE/ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUS2017-07-06a50c72e98297…
2026-08-01 22:54:322026-06A204406-002TOPOTECAN HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUSAP2017-07-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204406-002AP1a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopotecanTOPOTECANAccord Healthcare Inc.7636bc1e-77b6-46ad-9df0-c8bb1c5e503f2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204406
application number: ANDA204406
ndc (product): 16729-243

Additional Listing Data#

Finished product
Yes
Brand name base
Topotecan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPOTECAN1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7M7YKX2N15Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
637549Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7636bc1e-77b6-46ad-9df0-c8bb1c5e503fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
cbf6bf79-4ea9-419f-b7df-eefa780730bfProduct name220180125
19c78384-80c8-23c8-a4e6-c197ed91c59eProduct name120140508
302dcbc5-1902-d63c-93ac-bac5e14c2822Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-243-30Topotecan1 in 1 CARTONINJECTION18
16729-243-30Topotecan1 mL in 1 VIAL, MULTI-DOSEINJECTION18
16729-243-31Topotecan4 mL in 1 VIAL, MULTI-DOSEINJECTION48
16729-243-31Topotecan1 in 1 CARTONINJECTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-243-31ML - Milliliter16729-24352266a3b-45b8-4077-8c1e-6c3c8c059a5c12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-243TOPOTECAN INJECTION [ACCORD HEALTHCARE INC.]7Current NDC, Legacy NDC, 4 package rows20240216_7636bc1e-77b6-46ad-9df0-c8bb1c5e503f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637549topotecan 1 MG/ML Injectable SolutionPSN7636bc1e-77b6-46ad-9df0-c8bb1c5e503f8
637549topotecan 1 MG/ML Injectable SolutionSCD7636bc1e-77b6-46ad-9df0-c8bb1c5e503f8
637549topotecan (as topotecan hydrochloride) 1 MG/ML Injectable SolutionSY7636bc1e-77b6-46ad-9df0-c8bb1c5e503f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-243-30167290243301 in 1 CARTONHistorical
16729-243-31167290243311 VIAL, MULTI-DOSE in 1 CARTON (16729-243-31) / 4 mL in 1 VIAL, MULTI-DOSE2020-07-080000-00-00NoNoCurrent