mitosol

Generic: mitomycin

Labeler: mobius therapeutics llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mitosol
Generic Name mitomycin
Labeler mobius therapeutics llc
Dosage Form KIT
Manufacturer
Mobius Therapeutics LLC

Identifiers & Regulatory

Product NDC 49771-002
Product ID 49771-002_ffbaf9a3-07ba-4b4f-ad79-d0ec5dcf84d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022572
Listing Expiration 2026-12-31
Marketing Start 2012-02-08

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49771002
Hyphenated Format 49771-002

Supplemental Identifiers

RxCUI
1244553 1244558

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 mitosol (source: ndc)
Generic Name mitomycin (source: ndc)
Application Number NDA022572 (source: ndc)

Resolved Composition

Strengths
  • 0.2 mg
  • 0.4 mg
  • 0.2 mg/ml
  • 1 ml
source: label
Packaging
  • 3 TRAY in 1 CARTON (49771-002-03) / 1 KIT in 1 TRAY (49771-002-01) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

49771-002-03 3 TRAY in 1 CARTON (49771-002-03) / 1 KIT in 1 TRAY (49771-002-01) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Mitosol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "ffbaf9a3-07ba-4b4f-ad79-d0ec5dcf84d7", "openfda": {"rxcui": ["1244553", "1244558"], "spl_set_id": ["244002c6-c61d-43fe-9326-072797113979"], "manufacturer_name": ["Mobius Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 TRAY in 1 CARTON (49771-002-03)  / 1 KIT in 1 TRAY (49771-002-01)  *  1 mL in 1 VIAL, SINGLE-USE *  1 mL in 1 SYRINGE, GLASS", "package_ndc": "49771-002-03", "marketing_start_date": "20120208"}], "brand_name": "Mitosol", "product_id": "49771-002_ffbaf9a3-07ba-4b4f-ad79-d0ec5dcf84d7", "dosage_form": "KIT", "product_ndc": "49771-002", "generic_name": "mitomycin", "labeler_name": "Mobius Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mitosol", "application_number": "NDA022572", "marketing_category": "NDA", "marketing_start_date": "20120208", "listing_expiration_date": "20261231"}