Home NDC 0904-7466 mycophenolate mofetil
Product NDC 0904-7466
11-digit product format 009047466
Labeler code 0904
Product ID 0904-7466_ee7d4d25-3ca2-4937-9c91-ef7961ce3fe6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mycophenolate mofetil
Dosage form CAPSULE
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA200197
Marketing category ANDA
Marketing start 2025-12-11
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 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 A200197-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200197-001 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 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200197-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2013-06-13 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 250 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 199058 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 0904-7466-61 mycophenolate mofetil 100 in 1 CARTON CAPSULE 100 2 0904-7466-61 mycophenolate mofetil 1 in 1 BLISTER PACK CAPSULE 1 2
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join mycophenolate mofetil MYCOPHENOLATE MOFETIL Major Pharmaceuticals 6abc5727-ee8e-43ad-ab39-0eef2feb257a 2026-07-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200197 application number: ANDA200197 ndc (product): 0904-7466 Mycophenolate Mofetil MYCOPHENOLATE MOFETIL Ascend Laboratories, LLC 9f84ea84-2d8b-4d91-a33f-7dfb5df937dc 2026-03-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200197 application number: ANDA200197 mycophenolate mofetil MYCOPHENOLATE MOFETIL AvPAK fbbe6521-0e21-5372-e053-6394a90ae5e4 2026-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200197 application number: ANDA200197 mycophenolate mofetil MYCOPHENOLATE MOFETIL American Health Packaging 75a76397-bb62-4014-8488-949a711b25f0 2025-03-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200197 application number: ANDA200197
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0904-7466-61 00904746661 100 BLISTER PACK in 1 CARTON (0904-7466-61) / 1 CAPSULE in 1 BLISTER PACK 100 blister pack 2025-12-11 No No Current