FDA.reportPublic FDA data

Mycophenolic Acid

Product NDC
72322-1048
Requested package NDC
72322-1048-2
11-digit product format
723221048
Labeler code
72322
Product ID
72322-1048_bbab286d-00d9-9e22-e053-2995a90a5a9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolic Acid
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
AMTA LABS LIMITED
Application
ANDA214376
Marketing category
ANDA
Marketing start
2021-12-31
Marketing end
0000-00-00
Substance
MYCOPHENOLATE SODIUM
Active strength
180 mg/1
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72322-104872322-1048-2DDiscontinued 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214376-001MYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2021-02-10
A214376-002MYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2021-02-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A214376-001AB
A214376-002AB

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 22:54:322026-06A214376-001MYCOPHENOLATE SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2021-02-10a50c72e98297…
2026-08-01 22:54:322026-06A214376-002MYCOPHENOLATE SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2021-02-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214376-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A214376-002AB1a50c72e98297…

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
Mycophenolic AcidMYCOPHENOLIC ACIDSlate Run Pharmaceuticals, LLCc1ce92ef-4102-1487-e053-2995a90ac5212026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214376
application number: ANDA214376

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72322-1048-12024-11-27C16284748780-1f386c64a-1695-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS. MYCOPHENOLIC ACID delayed-release tablets, for oral use Initial U.S. Approval: 2004
72322-1048-22024-11-27C16284748780-1f386c64a-1695-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS. MYCOPHENOLIC ACID delayed-release tablets, for oral use Initial U.S. Approval: 2004
72322-1048-12023-01-30C16284748780-1f386c64a-1695-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS. MYCOPHENOLIC ACID delayed-release tablets, for oral use Initial U.S. Approval: 2004
72322-1048-22023-01-30C16284748780-1f386c64a-1695-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS. MYCOPHENOLIC ACID delayed-release tablets, for oral use Initial U.S. Approval: 2004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72322-1048-2723221048021000 TABLET, DELAYED RELEASE in 1 BOTTLE (72322-1048-2) 2021-12-310000-00-00NoNoCurrent