Home NDC 0054-0166 Mycophenolate Mofetil
Product NDC 0054-0166
11-digit product format 000540166
Labeler code 0054
Product ID 0054-0166_d938a1b7-eed3-4e23-bfef-f88c443d9267
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mycophenolate Mofetil
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA065413
Marketing category ANDA
Marketing start 2008-07-29
Marketing end 2026-11-30
Substance MYCOPHENOLATE MOFETIL
Active strength 500 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065413-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL 2008-07-29
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065413-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-07-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Mycophenolate Mofetil Active Ingredients# Ingredient, Strength table Ingredient Strength MYCOPHENOLATE MOFETIL 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9242ECW6R0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199058 Internal RxNorm lookup 200060 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-0166-25 Mycophenolate Mofetil 100 in 1 BOTTLE TABLET 100 21 0054-0166-29 Mycophenolate Mofetil 500 in 1 BOTTLE TABLET 500 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MYCOPHENOLATE MOFETIL ACTIVE INGREDIENT 9242ECW6R0 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10 MYCOPHENOLIC ACID ACTIVE MOIETY HU9DX48N0T MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10 GELATIN INACTIVE INGREDIENT 2G86QN327L MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10 POVIDONES INACTIVE INGREDIENT FZ989GH94E MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [ROXANE LABORATORIES, INC] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0166 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [HIKMA PHARMACEUTICALS USA INC.] 20 Current NDC, Legacy NDC, 2 package rows 20220924_e94895d9-f040-4a75-9f04-9814238b8f3c.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-0166-25 00054016625 100 TABLET in 1 BOTTLE (0054-0166-25) 100 tablet 2008-07-29 0000-00-00 No No Current 0054-0166-29 00054016629 500 TABLET in 1 BOTTLE (0054-0166-29) 500 tablet 2008-07-29 0000-00-00 No No Current