FDA.reportPublic FDA data

mycophenolate mofetil

Product NDC
60219-2135
11-digit product format
602192135
Labeler code
60219
Product ID
60219-2135_8452e58d-aaba-4911-bed5-7f317dce9cb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolate mofetil
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA090606
Marketing category
ANDA
Marketing start
2022-07-01
Marketing end
0000-00-00
Substance
MYCOPHENOLATE MOFETIL
Active strength
500 mg/1
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct60219-2135DDiscontinued by firm2026-08-03
excluded packagepackage60219-213560219-2135-1DDiscontinued by firm2026-08-03
excluded packagepackage60219-213560219-2135-5DDiscontinued by firm2026-08-03

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
A090606-001MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL500MGTABLET / ORAL2010-07-16

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 22:54:322026-06A090606-001MYCOPHENOLATE MOFETIL500MGTABLET / ORAL2010-07-16a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-2135-1EA - Each60219-213536db936d-ffc7-44ef-9257-c7a1266f7a5412022-09-12
60219-2135-5EA - Each60219-21354c5d208e-9b96-4de0-92cf-968d05fe505712022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-2135MYCOPHENOLATE MOFETIL TABLET [AMNEAL PHARMACEUTICALS NY LLC]6Legacy NDC20231229_eac2384a-146d-4001-8b05-1598c6166dbf.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60219-2135-160219213501100 TABLET in 1 BOTTLE (60219-2135-1) 100 tablet2022-07-010000-00-00NoNoCurrent
60219-2135-560219213505500 TABLET in 1 BOTTLE (60219-2135-5) 500 tablet2022-07-010000-00-00NoNoCurrent