Home NDC 63629-9582 mycophenolate mofetil
Product NDC 63629-9582
11-digit product format 636299582
Labeler code 63629
Product ID 63629-9582_06449b80-39e1-4ffa-8970-3263c823c008
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mycophenolate mofetil
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA065416
Marketing category ANDA
Marketing start 2009-05-04
Substance MYCOPHENOLATE MOFETIL
Active strength 500 mg/1
Pharmacologic classes Antimetabolite Immunosuppressant [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A065416-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065416-001 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 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065416-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 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 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 63629-9582-1 mycophenolate mofetil 120 in 1 BOTTLE TABLET 120 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-9582 MYCOPHENOLATE MOFETIL TABLET [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 1 package rows 20240511_0f1704e2-a66a-4be5-8127-ebb5947c7b64.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 63629-9582-1 63629958201 120 TABLET in 1 BOTTLE (63629-9582-1) 120 tablet 2022-11-15 0000-00-00 No No Current