FDA.reportPublic FDA data

TOPOTECAN

Product NDC
67457-662
Requested package NDC
67457-662-05
11-digit product format
674570662
Labeler code
67457
Product ID
67457-662_bad69ff7-d8b4-4436-a7f7-cbf49488c5e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOPOTECAN
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA206074
Marketing category
ANDA
Marketing start
2018-04-09
Marketing end
2022-02-28
Substance
TOPOTECAN HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67457-66267457-662-05DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206074-001TOPOTECAN HYDROCHLORIDETOPOTECAN HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUS2017-11-24

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 22:54:322026-06A206074-001TOPOTECAN HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUS2017-11-24a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-662-05ML - Milliliter67457-662d1f4d2c5-b2c3-4a5a-866e-dd02f83a48af12018-05-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-662-05674570662051 VIAL, SINGLE-DOSE in 1 CARTON (67457-662-05) > 4 mL in 1 VIAL, SINGLE-DOSE2018-04-092022-02-28NoNoCurrent