Home NDC 0781-5175 Mycophenolate Mofetil
Product NDC 0781-5175
11-digit product format 007815175
Labeler code 0781
Product ID 0781-5175_8d255117-cfa8-4893-8e2e-945eee7b12c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mycophenolate Mofetil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application ANDA065451
Marketing category ANDA
Marketing start 2008-10-15
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 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 A065451-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065451-001 AB
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 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065451-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2008-10-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Mycophenolate Mofetil
Listing expiration 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0781-5175-01 2023-08-02 These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995 0781-5175-05 2023-08-02 These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995 0781-5175-10 2023-08-02 These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995 0781-5175-01 2023-07-28 These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995 0781-5175-05 2023-07-28 These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995 0781-5175-10 2023-07-28 These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL capsules, for oral use MYCOPHENOLATE MOFETIL tablets, for oral use Initial U.S. Approval: 1995
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0781-5175-01 Mycophenolate Mofetil 100 in 1 BOTTLE TABLET, FILM COATED 100 20 0781-5175-05 Mycophenolate Mofetil 500 in 1 BOTTLE TABLET, FILM COATED 500 20 0781-5175-10 Mycophenolate Mofetil 1000 in 1 BOTTLE TABLET, FILM COATED 1000 20
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-5175 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [SANDOZ INC] 18 Current NDC, Legacy NDC, 3 package rows 20230803_99b2eb58-8d14-48fc-bbe1-aacb711a783e.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 Marketing start Marketing end Sample Exclude flag Status 0781-5175-01 00781517501 100 TABLET, FILM COATED in 1 BOTTLE (0781-5175-01) 2008-10-15 0000-00-00 No No Current 0781-5175-05 00781517505 500 TABLET, FILM COATED in 1 BOTTLE (0781-5175-05) 2008-10-15 0000-00-00 No No Current 0781-5175-10 00781517510 1000 TABLET, FILM COATED in 1 BOTTLE (0781-5175-10) 2008-10-15 0000-00-00 No No Current