Home NDC 0143-9260 mesna
Product NDC 0143-9260
11-digit product format 001439260
Labeler code 0143
Product ID 0143-9260_a8d40e08-983c-4377-ac75-a68199d8a4ab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mesna
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA075739
Marketing category ANDA
Marketing start 2004-02-23
Substance MESNA
Active strength 100 mg/mL
Pharmacologic classes Cytoprotective Agent [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A075739-001 MESNA MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2004-01-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075739-001 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 2026-08-01 22:54:32 2026-06 A075739-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2004-01-09 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A075739-001 AP 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base mesna
Listing expiration 2026-12-31 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 0143-9260-01 mesna 1 in 1 CARTON INJECTION, SOLUTION 1 7 0143-9260-01 mesna 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9260 MESNA INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 7 Current NDC, 2 package rows 20230504_8012b97b-4e39-451f-8e04-542d196e8bc6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0143-9260-01 00143926001 1 VIAL, MULTI-DOSE in 1 CARTON (0143-9260-01) / 10 mL in 1 VIAL, MULTI-DOSE 2004-02-23 No No Current