Mycophenolic Acid

Product NDC
68084-907
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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091558-001MYCOPHENOLATE SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091558-002MYCOPHENOLATE SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091558-001MYCOPHENOLATE SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091558-002MYCOPHENOLATE SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091558-001MYCOPHENOLIC ACID180MGTABLET, DELAYED RELEASE / ORALAB2012-08-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091558-002MYCOPHENOLIC ACID360MGTABLET, DELAYED RELEASE / ORALAB2014-08-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091558-001MYCOPHENOLIC SODIUMEQ 180MG BASETABLET, DELAYED RELEASE / ORALAB2012-08-21782e0a99824c…
2021-12-28 21:50 UTC2021-12A091558-002MYCOPHENOLIC SODIUMEQ 360MG BASETABLET, DELAYED RELEASE / ORALAB2014-08-19782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091558-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091558-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091558-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091558-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091558-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091558-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091558-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091558-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091558-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091558-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091558-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091558-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091558-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091558-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091558-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091558-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091558-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091558-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091558-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091558-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091558-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091558-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091558-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091558-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091558-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091558-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091558-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091558-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091558-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091558-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091558-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091558-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091558-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091558-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091558-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091558-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091558-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091558-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091558-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091558-002AB1782e0a99824c…

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 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
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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 (product): 68084-907
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

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
68084-907-11680840907111 in 1 BLISTER PACKHistorical
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