Home NDC 68254-5003 MYCOPHENOLATE MOFETIL
Product NDC 68254-5003
11-digit product format 682545003
Labeler code 68254
Product ID 68254-5003_6eb2ddd0-ab23-44ae-a1ce-acc44e4f7e29
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MYCOPHENOLATE MOFETIL
Dosage form TABLET
Route ORAL
Labeler CONCORD BIOTECH LIMITED
Application ANDA212087
Marketing category ANDA
Marketing start 2020-12-21
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 A212087-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212087-001 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.
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 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212087-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2020-07-31 a50c72e98297…
Observed Orange Book normalized TE history# 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68254-5003-1 MYCOPHENOLATE MOFETIL 30 in 1 BOTTLE TABLET 30 18 68254-5003-2 MYCOPHENOLATE MOFETIL 100 in 1 BOTTLE TABLET 100 18 68254-5003-3 MYCOPHENOLATE MOFETIL 500 in 1 BOTTLE TABLET 500 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68254-5003 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [CONCORD BIOTECH LIMITED] 17 Current NDC, Legacy NDC, 3 package rows 20240514_64ac00ee-298c-49cf-a91c-78019a0d014d.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 · 2 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 68254-5003-1 68254500301 30 TABLET in 1 BOTTLE (68254-5003-1) 30 tablet 2020-12-21 0000-00-00 No No Current 68254-5003-2 68254500302 100 TABLET in 1 BOTTLE (68254-5003-2) 100 tablet 2020-12-21 0000-00-00 No No Current 68254-5003-3 68254500303 500 TABLET in 1 BOTTLE (68254-5003-3) 500 tablet 2020-12-21 0000-00-00 No No Current