Topotecan

Product NDC: 50742-404
Requested package NDC: 50742-404-01
11-digit product format: 507420404
Labeler code: 50742
Product ID: 50742-404_97cb281e-9fae-44b4-acdb-38ce71f46baf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topotecan
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Ingenus Pharmaceuticals, LLC
Application: ANDA206962
Marketing category: ANDA
Marketing start: 2016-12-07
Marketing end: 0000-00-00
Substance: TOPOTECAN HYDROCHLORIDE
Active strength: 4 mg/4mL
Pharmacologic classes: Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50742-404	50742-404-01	D	Discontinued by firm		2026-07-31

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206962-001	TOPOTECAN HYDROCHLORIDE	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP		2016-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206962-001	AP

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	A206962-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP		2016-11-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A206962-001	AP	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50742-404-01	EA - Each	50742-404	ececa59a-ec62-471b-b980-35e7dff5ed3d	1	2017-03-06

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
956S425ZCY	TOPOTECAN HYDROCHLORIDE	119413-54-6	TOPOTECAN HYDROCHLORIDE
7M7YKX2N15	TOPOTECAN	123948-87-8	Topotecan

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50742-404-01	50742040401	4 mL in 1 VIAL (50742-404-01)	4 ml	2016-12-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topotecan	Ingenus Pharmaceuticals, LLC \| Novast Laboratories , Ltd. \| Ingenus Pharmaceuticals GmbH	2020-01-22	HUMAN PRESCRIPTION DRUG LABEL	10