FDA.reportPublic FDA data

Topotecan

Product NDC
0703-4714
Requested package NDC
0703-4714-01
11-digit product format
007034714
Labeler code
0703
Product ID
0703-4714_ecf75b05-d006-403c-a5b6-c64c632e6755
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topotecan
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Teva Parenteral Medicines, Inc.
Application
NDA022453
Marketing category
NDA
Marketing start
2013-05-21
Marketing end
0000-00-00
Substance
TOPOTECAN HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage0703-47140703-4714-01DDiscontinued 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
0703-4714-01ML - Milliliter0703-4714c737449c-b2fc-4d32-adac-22f4908d83e412013-06-04
0703-4714-71ML - Milliliter0703-47146d2570f7-0a49-4a5c-abbd-73db6e1ad5f012013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPOTECAN HYDROCHLORIDEACTIVE INGREDIENT956S425ZCYTOPOTECAN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]4
TOPOTECANACTIVE MOIETY7M7YKX2N15TOPOTECAN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBTOPOTECAN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]4
MANNITOLINACTIVE INGREDIENT3OWL53L36ATOPOTECAN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOPOTECAN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]4
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HTOPOTECAN INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0703-4714-01007034714011 VIAL, SINGLE-USE in 1 CARTON (0703-4714-01) > 4 mL in 1 VIAL, SINGLE-USE (0703-4714-71) 2013-05-210000-00-00NoNoCurrent