Home NDC 70860-209 Mesna
Product NDC 70860-209
11-digit product format 708600209
Labeler code 70860
Product ID 70860-209_6c0a2b1a-2713-4d47-b0c9-c349957a1f1d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mesna
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Athenex Pharmaceutical Division, LLC.
Application ANDA206992
Marketing category ANDA
Marketing start 2018-02-28
Marketing end 0000-00-00
Substance MESNA
Active strength 100 mg/mL
Pharmacologic classes Cytoprotective Agent [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 1 · 36 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 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.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mesna MESNA INJECTION Gland Pharma Limited a7af968c-05cf-4438-94ba-96a2baf9c367 2022-10-07 Warnings, Adverse reactions Exact identifier application applno (ANDA): 206992 application number: ANDA206992
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70860-209-10 70860020910 1 VIAL, MULTI-DOSE in 1 CARTON (70860-209-10) > 10 mL in 1 VIAL, MULTI-DOSE 2018-02-28 0000-00-00 No No Current 70860-209-11 70860020911 10 VIAL, MULTI-DOSE in 1 CARTON (70860-209-11) > 10 mL in 1 VIAL, MULTI-DOSE 2018-02-28 0000-00-00 No No Current