FDA.reportPublic FDA data

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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70860-209DDiscontinued by firm2026-07-31
excluded packagepackage70860-20970860-209-10DDiscontinued by firm2026-07-31
excluded packagepackage70860-20970860-209-11DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206992-001MESNAMESNA100MG/MLINJECTABLE / INTRAVENOUSAP2017-12-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A206992-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A206992-001MESNA100MG/MLINJECTABLE / INTRAVENOUSAP2017-12-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206992-001AP1a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MesnaMESNA INJECTIONGland Pharma Limiteda7af968c-05cf-4438-94ba-96a2baf9c3672022-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206992
application number: ANDA206992

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-209-10ML - Milliliter70860-20976b95ac3-d1cc-4717-a8c5-3017e94065fa12018-05-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70860-209-10708600209101 VIAL, MULTI-DOSE in 1 CARTON (70860-209-10) > 10 mL in 1 VIAL, MULTI-DOSE2018-02-280000-00-00NoNoCurrent
70860-209-117086002091110 VIAL, MULTI-DOSE in 1 CARTON (70860-209-11) > 10 mL in 1 VIAL, MULTI-DOSE2018-02-280000-00-00NoNoCurrent