Home NDC 51079-379 Mycophenolate Mofetil
Product NDC 51079-379
11-digit product format 510790379
Labeler code 51079
Product ID 51079-379_d43aef74-43df-6315-e053-2a95a90ab4c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mycophenolate mofetil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Institutional Inc.
Application ANDA065521
Marketing category ANDA
Marketing start 2009-06-01
Marketing end 2030-01-31
Substance MYCOPHENOLATE MOFETIL
Active strength 500 mg/1
Pharmacologic classes Antimetabolite Immunosuppressant [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065521-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL 2009-05-04
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL 2009-05-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MYCOPHENOLATE MOFETIL ACTIVE INGREDIENT 9242ECW6R0 MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 MYCOPHENOLIC ACID ACTIVE MOIETY HU9DX48N0T MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 AMMONIA INACTIVE INGREDIENT 5138Q19F1X MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 GELATIN INACTIVE INGREDIENT 2G86QN327L MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 POVIDONES INACTIVE INGREDIENT FZ989GH94E MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 SHELLAC INACTIVE INGREDIENT 46N107B71O MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 TALC INACTIVE INGREDIENT 7SEV7J4R1U MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MYCOPHENOLATE MOFETIL TABLET MYCOPHENOLATE MOFETIL CAPSULE [CARDINAL HEALTH] 6 MYCOPHENOLATE MOFETIL ACTIVE INGREDIENT 9242ECW6R0 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 MYCOPHENOLIC ACID ACTIVE MOIETY HU9DX48N0T MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 AMMONIA INACTIVE INGREDIENT 5138Q19F1X MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51079-379 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 13 Legacy NDC 20250327_52907069-4a29-4351-a830-a9ee86b5ff7c.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51079-379-20 51079037920 100 BLISTER PACK in 1 CARTON (51079-379-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-379-01) 100 blister pack 2009-06-01 0000-00-00 No No Current