Home NDC 59651-624-05 Mycophenolate mofetil
Product NDC 59651-624
Requested package NDC 59651-624-05
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 44 .
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 2026-10-15 13:18:30 2026-09 A217828-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2024-01-05 c2088c7a36db…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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-624-05 59651062405 500 CAPSULE in 1 BOTTLE (59651-624-05) 500 capsule 2024-01-05 No No Current