Home NDC 59651-624 Mycophenolate mofetil
Product NDC 59651-624
11-digit product format 596510624
Labeler code 59651
Product ID 59651-624_467c7d28-a9c8-4283-9ca9-92762b700ce0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mycophenolate mofetil
Dosage form CAPSULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA217828
Marketing category ANDA
Marketing start 2024-01-05
Substance MYCOPHENOLATE MOFETIL
Active strength 250 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 43 .
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 A217828-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217828-001 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 2026-09-14 22:38:34 2026-08 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 250 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59651-624-01 Mycophenolate mofetil 100 in 1 BOTTLE CAPSULE 100 2 59651-624-05 Mycophenolate mofetil 500 in 1 BOTTLE CAPSULE 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-624 MYCOPHENOLATE MOFETIL CAPSULE [AUROBINDO PHARMA LIMITED] 1 Current NDC, 2 package rows 20240112_3eb584dc-f72d-4545-96fa-ab3d47be41ce.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 Sample Exclude flag Status 59651-624-01 59651062401 100 CAPSULE in 1 BOTTLE (59651-624-01) 100 capsule 2024-01-05 No No Current 59651-624-05 59651062405 500 CAPSULE in 1 BOTTLE (59651-624-05) 500 capsule 2024-01-05 No No Current