United States · FDA National Drug Code directory

MITOMYCIN

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference
68083-502_5a0916d0-90cc-4ac2-82ba-e44138161853
Product NDC
68083-502
Form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Composition / generic term
MITOMYCIN
Labeler
Gland Pharma Limited
Marketing category
ANDA
Marketing start / end (source format)
20221122
Source listing expiry
20261231

Source-listed ingredients

  • MITOMYCIN — 40 mg/80mL

These values do not establish equivalence or a dose recommendation.

Packages

  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-502-01) / 80 mL in 1 VIAL, SINGLE-DOSE · 68083-502-01

Source and coverage

Open FDA National Drug Code directory

Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

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