Home NDC 25021-201 Mesna
Product NDC 25021-201
11-digit product format 250210201
Labeler code 25021
Product ID 25021-201_b216cb2c-ff72-4b54-9486-404a23092128
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mesna
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA090913
Marketing category ANDA
Marketing start 2010-12-01
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 72 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A090913-001 MESNA MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090913-001 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 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090913-001 MESNA 100MG/ML INJECTABLE / INTRAVENOUS AP 2010-04-13 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 25021-201-10 Mesna 10 mL in 1 VIAL INJECTION, SOLUTION 10 10 25021-201-10 Mesna 1 in 1 CARTON INJECTION, SOLUTION 1 10 25021-201-11 Mesna 10 in 1 CARTON INJECTION, SOLUTION 10 10 25021-201-11 Mesna 10 mL in 1 VIAL INJECTION, SOLUTION 10 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded mesna ACTIVE INGREDIENT NR7O1405Q9 MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 4 2-Mercaptoethanesulfonic Acid ACTIVE MOIETY VHD28S0H7F MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 4 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 4 edetate disodium INACTIVE INGREDIENT 7FLD91C86K MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 4 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 4 water INACTIVE INGREDIENT 059QF0KO0R MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 4 mesna ACTIVE INGREDIENT NR7O1405Q9 MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2 2-Mercaptoethanesulfonic Acid ACTIVE MOIETY VHD28S0H7F MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2 edetate disodium INACTIVE INGREDIENT 7FLD91C86K MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2 water INACTIVE INGREDIENT 059QF0KO0R MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-201 MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 10 Current NDC, Legacy NDC, 4 package rows 20250313_2a2a526f-636b-7920-4261-6c626f612a2a.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 Units Marketing start Marketing end Sample Exclude flag Status 25021-201-10 25021020110 1 VIAL in 1 CARTON (25021-201-10) / 10 mL in 1 VIAL 1 vial 2010-12-01 0000-00-00 No No Current 25021-201-11 25021020111 10 VIAL in 1 CARTON (25021-201-11) / 10 mL in 1 VIAL 10 vial 2010-12-01 0000-00-00 No No Current 25021-201-68 25021020168 1 VIAL in 1 CARTON (25021-201-68) > 10 mL in 1 VIAL 1 vial 2013-04-30 0000-00-00 No No Current 25021-201-69 25021020169 10 VIAL in 1 CARTON (25021-201-69) > 10 mL in 1 VIAL 10 vial 2013-04-30 0000-00-00 No No Current