valrubicin intravesical solution

Generic: valrubicin intravesical solution

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valrubicin intravesical solution
Generic Name valrubicin intravesical solution
Labeler hikma pharmaceuticals usa inc.
Dosage Form SOLUTION, CONCENTRATE
Routes
INTRAVESICAL
Active Ingredients

valrubicin 40 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 24201-101
Product ID 24201-101_f2385edd-45ba-4ce8-97a0-ac301d067536
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206430
Listing Expiration 2026-12-31
Marketing Start 2019-04-23

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24201101
Hyphenated Format 24201-101

Supplemental Identifiers

RxCUI
313567
UNII
2C6NUM6878

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 valrubicin intravesical solution (source: ndc)
Generic Name valrubicin intravesical solution (source: ndc)
Application Number ANDA206430 (source: ndc)
Routes
INTRAVESICAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 4 VIAL in 1 CARTON (24201-101-04) / 5 mL in 1 VIAL
source: ndc

Packages (1)

24201-101-04 4 VIAL in 1 CARTON (24201-101-04) / 5 mL in 1 VIAL

Ingredients (1)

valrubicin (40 mg/mL)

Linked Drug Pages (1)

Valrubicin Intravesical Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVESICAL"], "spl_id": "f2385edd-45ba-4ce8-97a0-ac301d067536", "openfda": {"unii": ["2C6NUM6878"], "rxcui": ["313567"], "spl_set_id": ["8739ae02-e4c5-0fa2-e053-2a91aa0a1b74"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL in 1 CARTON (24201-101-04)  / 5 mL in 1 VIAL", "package_ndc": "24201-101-04", "marketing_start_date": "20190423"}], "brand_name": "Valrubicin Intravesical Solution", "product_id": "24201-101_f2385edd-45ba-4ce8-97a0-ac301d067536", "dosage_form": "SOLUTION, CONCENTRATE", "product_ndc": "24201-101", "generic_name": "Valrubicin Intravesical Solution", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valrubicin Intravesical Solution", "active_ingredients": [{"name": "VALRUBICIN", "strength": "40 mg/mL"}], "application_number": "ANDA206430", "marketing_category": "ANDA", "marketing_start_date": "20190423", "listing_expiration_date": "20261231"}