FDA.reportPublic FDA data

topotecan

Product NDC
25021-236
11-digit product format
250210236
Labeler code
25021
Product ID
25021-236_9a438a29-0a0f-44e6-978c-32d098c41047
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topotecan
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
NDA022453
Marketing category
NDA
Marketing start
2014-12-15
Marketing end
2021-01-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct25021-236DDiscontinued by firm2026-07-31
excluded packagepackage25021-23625021-236-04DDiscontinued 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
N022453-001TOPOTECAN HYDROCHLORIDETOPOTECAN HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUS2012-12-20

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 22:54:322026-06N022453-001TOPOTECAN HYDROCHLORIDEEQ 4MG BASE/4ML (EQ 1MG BASE/ML)SOLUTION / INTRAVENOUS2012-12-20a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-236-04ML - Milliliter25021-2367b9e21b4-34a4-4ff8-86a3-9333f2ed0dc012015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
topotecan hydrochlorideACTIVE INGREDIENT956S425ZCYTOPOTECAN INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS]3
topotecanACTIVE MOIETY7M7YKX2N15TOPOTECAN INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS]3
hydrochloric acidINACTIVE INGREDIENTQTT17582CBTOPOTECAN INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS]3
mannitolINACTIVE INGREDIENT3OWL53L36ATOPOTECAN INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS]3
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITOPOTECAN INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS]3
tartaric acidINACTIVE INGREDIENTW4888I119HTOPOTECAN INJECTION, SOLUTION, CONCENTRATE [SAGENT PHARMACEUTICALS]3