topotecan hydrochloride

Generic: topotecan hydrochloride

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topotecan hydrochloride
Generic Name topotecan hydrochloride
Labeler accord healthcare, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

topotecan hydrochloride 4 mg/4mL

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-151
Product ID 16729-151_23a75b4a-a836-a01d-e063-6394a90a67b3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202351
Listing Expiration 2026-12-31
Marketing Start 2013-07-23

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729151
Hyphenated Format 16729-151

Supplemental Identifiers

RxCUI
1799416
UPC
0316729151313
UNII
956S425ZCY

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name topotecan hydrochloride (source: ndc)
Generic Name topotecan hydrochloride (source: ndc)
Application Number ANDA202351 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/4mL
source: ndc
Packaging
  • 1 VIAL in 1 PACKAGE (16729-151-31) / 4 mL in 1 VIAL
source: ndc

Packages (1)

16729-151-31 1 VIAL in 1 PACKAGE (16729-151-31) / 4 mL in 1 VIAL

Ingredients (1)

topotecan hydrochloride (4 mg/4mL)

Linked Drug Pages (1)

topotecan hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "23a75b4a-a836-a01d-e063-6394a90a67b3", "openfda": {"upc": ["0316729151313"], "unii": ["956S425ZCY"], "rxcui": ["1799416"], "spl_set_id": ["729b2b22-1344-44f3-b614-14f6ec3c263e"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 PACKAGE (16729-151-31)  / 4 mL in 1 VIAL", "package_ndc": "16729-151-31", "marketing_start_date": "20130723"}], "brand_name": "topotecan hydrochloride", "product_id": "16729-151_23a75b4a-a836-a01d-e063-6394a90a67b3", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "16729-151", "generic_name": "topotecan hydrochloride", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "topotecan hydrochloride", "active_ingredients": [{"name": "TOPOTECAN HYDROCHLORIDE", "strength": "4 mg/4mL"}], "application_number": "ANDA202351", "marketing_category": "ANDA", "marketing_start_date": "20130723", "listing_expiration_date": "20261231"}