jelmyto

Generic: mitomycin

Labeler: urogen pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name jelmyto
Generic Name mitomycin
Labeler urogen pharma, inc.
Dosage Form KIT
Manufacturer
UroGen Pharma, Inc.

Identifiers & Regulatory

Product NDC 72493-103
Product ID 72493-103_e545c060-c1c8-43af-b77e-7e951af59e1d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211728
Listing Expiration 2026-12-31
Marketing Start 2020-05-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72493103
Hyphenated Format 72493-103

Supplemental Identifiers

RxCUI
2375818 2375823

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 jelmyto (source: ndc)
Generic Name mitomycin (source: ndc)
Application Number NDA211728 (source: ndc)

Resolved Composition

Strengths
  • 40 mg
  • 20 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (72493-103-03) * 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72493-101-40) * 20 mL in 1 VIAL, SINGLE-DOSE (72493-102-20)
source: ndc

Packages (1)

72493-103-03 1 KIT in 1 CARTON (72493-103-03) * 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72493-101-40) * 20 mL in 1 VIAL, SINGLE-DOSE (72493-102-20)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

JELMYTO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "e545c060-c1c8-43af-b77e-7e951af59e1d", "openfda": {"rxcui": ["2375818", "2375823"], "spl_set_id": ["3d3d5053-5427-4a68-a40b-edb60699521e"], "manufacturer_name": ["UroGen Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (72493-103-03)  *  1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72493-101-40)  *  20 mL in 1 VIAL, SINGLE-DOSE (72493-102-20)", "package_ndc": "72493-103-03", "marketing_start_date": "20200501"}], "brand_name": "JELMYTO", "product_id": "72493-103_e545c060-c1c8-43af-b77e-7e951af59e1d", "dosage_form": "KIT", "product_ndc": "72493-103", "generic_name": "mitomycin", "labeler_name": "UroGen Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "JELMYTO", "application_number": "NDA211728", "marketing_category": "NDA", "marketing_start_date": "20200501", "listing_expiration_date": "20261231"}