Home NDC 55150-520 MESNA
Product NDC 55150-520
11-digit product format 551500520
Labeler code 55150
Product ID 55150-520_49e9c804-9e88-4774-8faf-35bd61b3a8e9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MESNA
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA220518
Marketing category ANDA
Marketing start 2026-01-27
Substance MESNA
Active strength 100 mg/mL
Pharmacologic classes Cytoprotective Agent [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220518-001 MESNA MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2026-01-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220518-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A220518-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2026-01-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A220518-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2026-01-27 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220518-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2026-01-27 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A220518-001 AP 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A220518-001 AP 1 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220518-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base MESNA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MESNA 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NR7O1405Q9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204870 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55150-520-01 MESNA 01 in 1 BOX INJECTION, SOLUTION 01 1 55150-520-01 MESNA 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 55150-520-01 55150052001 1 VIAL, MULTI-DOSE in 1 BOX (55150-520-01) / 10 mL in 1 VIAL, MULTI-DOSE 2026-01-27 No No Current