topotecan hydrochloride

Generic: topotecan hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topotecan hydrochloride
Generic Name topotecan hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

topotecan hydrochloride 4 mg/4mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-762
Product ID 63323-762_7f91362f-6b55-4518-b034-b54aa5881204
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091089
Listing Expiration 2027-12-31
Marketing Start 2010-11-30

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323762
Hyphenated Format 63323-762

Supplemental Identifiers

RxCUI
1799416
UPC
0363323762100
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 ANDA091089 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/4mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX (63323-762-10) / 4 mL in 1 VIAL
source: ndc

Packages (1)

63323-762-10 1 VIAL in 1 BOX (63323-762-10) / 4 mL in 1 VIAL

Ingredients (1)

topotecan hydrochloride (4 mg/4mL)

Linked Drug Pages (2)

Topotecan Hydrochloride ndc-match (0.9) Topotecan Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7f91362f-6b55-4518-b034-b54aa5881204", "openfda": {"upc": ["0363323762100"], "unii": ["956S425ZCY"], "rxcui": ["1799416"], "spl_set_id": ["b6019088-cd94-43b4-b5ce-ba20b6b8021e"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX (63323-762-10)  / 4 mL in 1 VIAL", "package_ndc": "63323-762-10", "marketing_start_date": "20101130"}], "brand_name": "Topotecan Hydrochloride", "product_id": "63323-762_7f91362f-6b55-4518-b034-b54aa5881204", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "63323-762", "generic_name": "TOPOTECAN HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topotecan Hydrochloride", "active_ingredients": [{"name": "TOPOTECAN HYDROCHLORIDE", "strength": "4 mg/4mL"}], "application_number": "ANDA091089", "marketing_category": "ANDA", "marketing_start_date": "20101130", "listing_expiration_date": "20271231"}