Home NDC 0054-0163 Mycophenolate Mofetil
Product NDC 0054-0163
11-digit product format 000540163
Labeler code 0054
Product ID 0054-0163_d938a1b7-eed3-4e23-bfef-f88c443d9267
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mycophenolate Mofetil
Dosage form CAPSULE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA065410
Marketing category ANDA
Marketing start 2008-07-29
Substance MYCOPHENOLATE MOFETIL
Active strength 250 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 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 A065410-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE / 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 · 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 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL 2008-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065410-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2008-07-29 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-0163-25 Mycophenolate Mofetil 100 in 1 BOTTLE CAPSULE 100 21 0054-0163-29 Mycophenolate Mofetil 500 in 1 BOTTLE CAPSULE 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 MYCOPHENOLATE MOFETIL ACTIVE INGREDIENT 9242ECW6R0 MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] 1 MYCOPHENOLIC ACID ACTIVE MOIETY HU9DX48N0T MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] 1 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MYCOPHENOLATE MOFETIL CAPSULE [AVERA MCKENNAN HOSPITAL] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0163 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 0054-0163-25 00054016325 100 CAPSULE in 1 BOTTLE (0054-0163-25) 100 capsule 2008-07-29 0000-00-00 No No Current 0054-0163-29 00054016329 500 CAPSULE in 1 BOTTLE (0054-0163-29) 500 capsule 2008-07-29 0000-00-00 No No Current