Home NDC 68083-161 Mesna
Product NDC 68083-161
11-digit product format 680830161
Labeler code 68083
Product ID 68083-161_b61d560c-02fd-4ae7-a6f7-fa7edb0a0d3f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mesna Injection
Dosage form SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA206992
Marketing category ANDA
Marketing start 2017-12-20
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 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 A206992-001 MESNA MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206992-001 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.
Product history page 1 of 2 · 42 observed 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 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206992-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2017-12-18 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 68083-161-01 Mesna 1 in 1 CARTON SOLUTION 1 10 68083-161-01 Mesna 10 mL in 1 VIAL, MULTI-DOSE SOLUTION 10 10 68083-161-10 Mesna 10 mL in 1 VIAL, MULTI-DOSE SOLUTION 10 10 68083-161-10 Mesna 10 in 1 CARTON SOLUTION 10 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-161 MESNA (MESNA INJECTION) SOLUTION [GLAND PHARMA LIMITED] 10 Current NDC, Legacy NDC, 4 package rows 20221008_a7af968c-05cf-4438-94ba-96a2baf9c367.zip
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 Marketing end Sample Exclude flag Status 68083-161-01 68083016101 1 VIAL, MULTI-DOSE in 1 CARTON (68083-161-01) / 10 mL in 1 VIAL, MULTI-DOSE 2017-12-20 0000-00-00 No No Current 68083-161-10 68083016110 10 VIAL, MULTI-DOSE in 1 CARTON (68083-161-10) / 10 mL in 1 VIAL, MULTI-DOSE 2017-12-20 0000-00-00 No No Current