Mycophenolate Mofetil

Product NDC
55154-6262
11-digit product format
551546262
Labeler code
55154
Product ID
55154-6262_700941b9-de3e-49c7-bca2-f85663cdf223
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolate mofetil
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA065520
Marketing category
ANDA
Marketing start
2011-10-25
Marketing end
2030-01-31
Substance
MYCOPHENOLATE MOFETIL
Active strength
250 mg/1
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55154-6262DDiscontinued by firm2026-08-17
excluded packagepackage55154-626255154-6262-0DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 22 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55154-6262-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55154-6262-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55154-6262-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55154-6262-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55154-6262-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55154-6262-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55154-6262-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55154-6262-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55154-6262-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55154-6262-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55154-6262-0367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A065520-001MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL250MGCAPSULE / ORAL2009-05-04

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORAL2009-05-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-043f01610625f2…
2019-09-15 20:21 UTC2019-09A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065520-001MYCOPHENOLATE MOFETIL250MGCAPSULE / ORALAB2009-05-04e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065520-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065520-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065520-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065520-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065520-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065520-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065520-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065520-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065520-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065520-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065520-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065520-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065520-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065520-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065520-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065520-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065520-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065520-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065520-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065520-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065520-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065520-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065520-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065520-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065520-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065520-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065520-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065520-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065520-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065520-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065520-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065520-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065520-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065520-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065520-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065520-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065520-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065520-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065520-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065520-001AB1cb3db0bc1861…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MYCOPHENOLATE MOFETILACTIVE INGREDIENT9242ECW6R0MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
MYCOPHENOLIC ACIDACTIVE MOIETYHU9DX48N0TMYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XMYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
GELATININACTIVE INGREDIENT2G86QN327LMYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EMYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
SHELLACINACTIVE INGREDIENT46N107B71OMYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
TALCINACTIVE INGREDIENT7SEV7J4R1UMYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH]6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-6262-05515462620010 BLISTER PACK in 1 BAG (55154-6262-0) > 1 CAPSULE in 1 BLISTER PACK10 blister pack2011-10-250000-00-00NoNoCurrent