FDA.reportPublic FDA data

Mycophenolic Acid

Product NDC
82293-013
11-digit product format
822930013
Labeler code
82293
Product ID
82293-013_1f0154d5-686f-170e-e063-6394a90a67e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolic Acid
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Novugen Pharma (USA) LLC.
Application
ANDA216637
Marketing category
ANDA
Marketing start
2024-09-01
Substance
MYCOPHENOLATE SODIUM
Active strength
360 mg/1
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A216637-001MYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2024-05-29
A216637-002MYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2024-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216637-001AB
A216637-002AB

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 22:54:322026-06A216637-001MYCOPHENOLATE SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2024-05-29a50c72e98297…
2026-08-01 22:54:322026-06A216637-002MYCOPHENOLATE SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2024-05-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216637-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A216637-002AB1a50c72e98297…

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 ACIDNovugen Pharma (USA) LLC.cbc3e916-09e2-4e6e-9e5e-98375f5e6d412024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216637
application number: ANDA216637
ndc (product): 82293-013

Additional Listing Data#

Finished product
Yes
Brand name base
Mycophenolic Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE SODIUM360 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WX877SQI1GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
485020Internal RxNorm lookup
485023Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cbc3e916-09e2-4e6e-9e5e-98375f5e6d41Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04b26d3d-97dc-48db-824b-10b299945382Product name820250224
1aa45098-03f9-4bf8-b28d-2566aa0f7f4bProduct name120250218
267b34ba-ace4-4048-9f21-d3c7ac983fc3Product name920210224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82293-013-10Mycophenolic Acid120 in 1 BOTTLETABLET, DELAYED RELEASE1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82293-013MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [NOVUGEN PHARMA (USA) LLC.]2Current NDC, 1 package rows20240901_cbc3e916-09e2-4e6e-9e5e-98375f5e6d41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485020mycophenolic acid 180 MG Delayed Release Oral TabletPSNcbc3e916-09e2-4e6e-9e5e-98375f5e6d412
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSNcbc3e916-09e2-4e6e-9e5e-98375f5e6d412
485020mycophenolic acid 180 MG Delayed Release Oral TabletSCDcbc3e916-09e2-4e6e-9e5e-98375f5e6d412
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCDcbc3e916-09e2-4e6e-9e5e-98375f5e6d412
485020mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral TabletSYcbc3e916-09e2-4e6e-9e5e-98375f5e6d412
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSYcbc3e916-09e2-4e6e-9e5e-98375f5e6d412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82293-013-1082293001310120 TABLET, DELAYED RELEASE in 1 BOTTLE (82293-013-10) 2024-09-01NoNoCurrent