Home NDC 0904-7074 mycophenolate mofetil
Product NDC 0904-7074
11-digit product format 009047074
Labeler code 0904
Product ID 0904-7074_d5342771-def9-4108-bb5b-4e866847affc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mycophenolate mofetil
Dosage form CAPSULE
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA090253
Marketing category ANDA
Marketing start 2009-05-04
Marketing end 0000-00-00
Substance MYCOPHENOLATE MOFETIL
Active strength 250 mg/1
Pharmacologic classes Antimetabolite Immunosuppressant [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0904-7074-61 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0904-7074-61 f5e01cc5f278…a2eaf40c39c3…
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 A090253-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE / 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 A090253-001 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 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090253-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7074 MYCOPHENOLATE MOFETIL CAPSULE [MAJOR PHARMACEUTICALS] 3 Legacy NDC 20240619_2692db29-45cd-41b3-84e4-f02bba13bc12.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-7074-61 00904707461 100 BLISTER PACK in 1 CARTON (0904-7074-61) > 1 CAPSULE in 1 BLISTER PACK 100 blister pack 2009-05-04 0000-00-00 No No Current