Mycophenolate Mofetil

Product NDC
0378-4472
11-digit product format
003784472
Labeler code
0378
Product ID
0378-4472_c55e1a32-db7a-4605-bab0-972a88414e7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mycophenolate mofetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA065521
Marketing category
ANDA
Marketing start
2009-05-04
Marketing end
2026-05-31
Substance
MYCOPHENOLATE MOFETIL
Active strength
500 mg/1
Pharmacologic classes
Antimetabolite Immunosuppressant [EPC]
NDC exclude flag
No
Current FDA listing
Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-4472DDiscontinued by firm2026-08-17
excluded packagepackage0378-44720378-4472-01DDiscontinued by firm2026-08-17
excluded packagepackage0378-44720378-4472-05DDiscontinued by firm2026-08-17

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
A065521-001MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL500MGTABLET / 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 06:07:402026-07A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORAL2009-05-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-043f01610625f2…
2019-09-15 20:21 UTC2019-09A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065521-001MYCOPHENOLATE MOFETIL500MGTABLET / ORALAB2009-05-04e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065521-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065521-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065521-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065521-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065521-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065521-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065521-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065521-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065521-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065521-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065521-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065521-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065521-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065521-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065521-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065521-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065521-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065521-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065521-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065521-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065521-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065521-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065521-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065521-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065521-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065521-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065521-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065521-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065521-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065521-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065521-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065521-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065521-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065521-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065521-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065521-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065521-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065521-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065521-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065521-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04b26d3d-97dc-48db-824b-10b299945382Product name820250224
1aa45098-03f9-4bf8-b28d-2566aa0f7f4bProduct name120250218
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
267b34ba-ace4-4048-9f21-d3c7ac983fc3Product name920210224
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-4472-01Mycophenolate Mofetil100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10020
0378-4472-05Mycophenolate Mofetil500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4472-01EA - Each0378-4472f0400782-21f7-4c68-aad8-3e7a04c1d39712012-07-24
0378-4472-05EA - Each0378-4472acfd72c2-7fc1-404a-a3bb-44b0573a93c512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MYCOPHENOLATE MOFETILACTIVE INGREDIENT9242ECW6R0MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
MYCOPHENOLIC ACIDACTIVE MOIETYHU9DX48N0TMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
AMMONIAINACTIVE INGREDIENT5138Q19F1XMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
GELATININACTIVE INGREDIENT2G86QN327LMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
POVIDONESINACTIVE INGREDIENTFZ989GH94EMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
SHELLACINACTIVE INGREDIENT46N107B71OMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]8
MYCOPHENOLATE MOFETILACTIVE INGREDIENT9242ECW6R0MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
MYCOPHENOLIC ACIDACTIVE MOIETYHU9DX48N0TMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
GELATININACTIVE INGREDIENT2G86QN327LMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]3
MYCOPHENOLATE MOFETILACTIVE INGREDIENT9242ECW6R0MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
MYCOPHENOLIC ACIDACTIVE MOIETYHU9DX48N0TMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-4472MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 2 package rows20250216_74c3a01e-9451-0f2f-6aab-8348047cb1f5.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mycophenolate MofetilMYCOPHENOLATE MOFETILAphena Pharma Solutions - Tennessee, LLC721564bc-7c0b-4418-ab49-0af362e74eb72024-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065521
application number: ANDA065521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-4472-0100378447201100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4472-01) 2009-05-040000-00-00NoNoCurrent
0378-4472-0500378447205500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4472-05) 2009-05-042026-05-31NoNoCurrent