TOPOTECAN HYDROCHLORIDE

Product NDC: 69097-262
Requested package NDC: 69097-262-68
11-digit product format: 690970262
Labeler code: 69097
Product ID: 69097-262_4e757b90-6761-4586-914f-6bc194402399
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TOPOTECAN HYDROCHLORIDE
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Cipla USA Inc.
Application: ANDA091199
Marketing category: ANDA
Marketing start: 2010-12-01
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: 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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69097-262	69097-262-68	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
A091199-001	TOPOTECAN HYDROCHLORIDE	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP		2010-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091199-001	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	A091199-001	TOPOTECAN HYDROCHLORIDE	EQ 4MG BASE/VIAL	INJECTABLE / INJECTION	AP		2010-12-01	`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	A091199-001	AP	1	`a50c72e98297…`

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
956S425ZCY	TOPOTECAN HYDROCHLORIDE	119413-54-6	TOPOTECAN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-262-68	69097026268	5 VIAL, SINGLE-DOSE in 1 CARTON (69097-262-68) > 4 mL in 1 VIAL, SINGLE-DOSE	2010-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TOPOTECAN HYDROCHLORIDE	Cipla USA Inc. \| Cipla Ltd.- Goa \| Cipla Limited, Bangalore	2019-11-12	HUMAN PRESCRIPTION DRUG LABEL	7