FDA.reportPublic FDA data

Mesalamine

Product NDC
69238-1274
11-digit product format
692381274
Labeler code
69238
Product ID
69238-1274_9be9840d-1169-4538-9c3f-8830d215f72d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mesalamine
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA210509
Marketing category
ANDA
Marketing start
2020-01-08
Marketing end
2023-05-01
Substance
MESALAMINE
Active strength
1000 mg/1
Pharmacologic classes
Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69238-1274DDiscontinued by firm2026-07-31
excluded packagepackage69238-127469238-1274-3DDiscontinued 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
A210509-001MESALAMINEMESALAMINE1GMSUPPOSITORY / RECTAL2020-01-02

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 22:54:322026-06A210509-001MESALAMINE1GMSUPPOSITORY / RECTAL2020-01-02a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1274-3EA - Each69238-127463cb7fa9-7036-4fa0-bcd2-2d8a3589b2c112020-07-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1274-36923812740330 SUPPOSITORY in 1 CARTON (69238-1274-3) 30 suppository2020-01-080000-00-00NoNoCurrent