topotecan

Generic: topotecan

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

Drug Facts

Product Profile

Brand Name topotecan
Generic Name topotecan
Labeler accord healthcare inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

topotecan 1 mg/mL

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-243
Product ID 16729-243_46296320-1014-df71-e063-6294a90ac862
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204406
Listing Expiration 2026-12-31
Marketing Start 2020-07-08

Pharmacologic Class

Established (EPC)
topoisomerase inhibitor [epc]
Mechanism of Action
topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729243
Hyphenated Format 16729-243

Supplemental Identifiers

RxCUI
637549
UPC
0316729243308
UNII
7M7YKX2N15
NUI
N0000175609 N0000000176

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 (source: ndc)
Generic Name topotecan (source: ndc)
Application Number ANDA204406 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (16729-243-31) / 4 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

16729-243-31 1 VIAL, MULTI-DOSE in 1 CARTON (16729-243-31) / 4 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

topotecan (1 mg/mL)

Linked Drug Pages (1)

Topotecan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "46296320-1014-df71-e063-6294a90ac862", "openfda": {"nui": ["N0000175609", "N0000000176"], "upc": ["0316729243308"], "unii": ["7M7YKX2N15"], "rxcui": ["637549"], "spl_set_id": ["7636bc1e-77b6-46ad-9df0-c8bb1c5e503f"], "pharm_class_epc": ["Topoisomerase Inhibitor [EPC]"], "pharm_class_moa": ["Topoisomerase Inhibitors [MoA]"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (16729-243-31)  / 4 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "16729-243-31", "marketing_start_date": "20200708"}], "brand_name": "Topotecan", "product_id": "16729-243_46296320-1014-df71-e063-6294a90ac862", "dosage_form": "INJECTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "16729-243", "generic_name": "Topotecan", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topotecan", "active_ingredients": [{"name": "TOPOTECAN", "strength": "1 mg/mL"}], "application_number": "ANDA204406", "marketing_category": "ANDA", "marketing_start_date": "20200708", "listing_expiration_date": "20261231"}