FDA.reportPublic FDA data

Mycophenolic Acid

Product NDC
68084-907
Requested package NDC
68084-907-21
11-digit product format
680840907
Labeler code
68084
Product ID
68084-907_27ea2d9a-52b6-818e-e063-6394a90a52c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mycophenolic Acid
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA091558
Marketing category
ANDA
Marketing start
2015-02-02
Substance
MYCOPHENOLATE SODIUM
Active strength
180 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
A091558-001MYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-21
A091558-002MYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091558-001AB
A091558-002AB

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 22:54:322026-06A091558-001MYCOPHENOLATE SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-21a50c72e98297…
2026-08-01 22:54:322026-06A091558-002MYCOPHENOLATE SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091558-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091558-002AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mycophenolic AcidMYCOPHENOLIC ACIDAmerican Health Packaging26b31126-4262-4a15-8a16-234c867631762026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091558
application number: ANDA091558
ndc (package): 68084-907-21
ndc (product): 68084-907
ndc11 (package): 68084090721
Mycophenolic AcidMYCOPHENOLIC ACIDMajor Pharmaceuticals93763b39-ba21-449b-bdc5-254ba57154e42026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091558
application number: ANDA091558
Mycophenolic AcidMYCOPHENOLIC ACIDGolden State Medical Supply, Inc.3a0a6ef4-fb2c-47be-82d7-d2675059c45b2025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091558
application number: ANDA091558
Mycophenolic AcidMYCOPHENOLIC ACIDApotex Corpc0efafa6-d249-f44a-fbf3-e6bd3acaf6f02025-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091558
application number: ANDA091558

Additional Listing Data#

Finished product
Yes
Brand name base
Mycophenolic Acid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPHENOLATE SODIUM180 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
26b31126-4262-4a15-8a16-234c86763176Available 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
68084-907-11Mycophenolic Acid1 in 1 BLISTER PACKTABLET, DELAYED RELEASE19
68084-907-21Mycophenolic Acid30 in 1 BOX, UNIT-DOSETABLET, DELAYED RELEASE309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-907-11EA - Each68084-907fb4cede4-b867-4a49-8885-87d0fb16f91812015-03-03
68084-907-21EA - Each68084-907b0c87035-76e1-4226-911c-2266ffb8d53112015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MYCOPHENOLATE SODIUMACTIVE INGREDIENTWX877SQI1GMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
mycophenolic acidACTIVE MOIETYHU9DX48N0TMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
METHYLCELLULOSE (400 MPA.S)INACTIVE INGREDIENTO0GN6F9B2YMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMMYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-907MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]9Current NDC, Legacy NDC, 2 package rows20241129_26b31126-4262-4a15-8a16-234c86763176.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485020mycophenolic acid 180 MG Delayed Release Oral TabletPSN26b31126-4262-4a15-8a16-234c867631769
485023mycophenolic acid 360 MG Delayed Release Oral TabletPSN26b31126-4262-4a15-8a16-234c867631769
485020mycophenolic acid 180 MG Delayed Release Oral TabletSCD26b31126-4262-4a15-8a16-234c867631769
485023mycophenolic acid 360 MG Delayed Release Oral TabletSCD26b31126-4262-4a15-8a16-234c867631769
485020mycophenolic acid (as mycophenolate sodium) 180 MG Delayed Release Oral TabletSY26b31126-4262-4a15-8a16-234c867631769
485023mycophenolic acid (as mycophenolate sodium) 360 MG Delayed Release Oral TabletSY26b31126-4262-4a15-8a16-234c867631769

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-907-216808409072130 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-907-21) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68084-907-11) 30 blister pack2015-02-020000-00-00NoNoCurrent