Home NDC 64380-726 Mycophenolate mofetil
Product NDC 64380-726
11-digit product format 643800726
Labeler code 64380
Product ID 64380-726_51752987-c49c-40b6-8fe2-1d1c99554312
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mycophenolate mofetil
Dosage form CAPSULE
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA090055
Marketing category ANDA
Marketing start 2010-11-06
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64380-726 64380-726-11 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64380-726 64380-726-11 D Discontinued by firm excluded / ndc_excluded.zip 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 A090055-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090055-001 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 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090055-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2010-06-10 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199058 Internal RxNorm lookup 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 64380-726-06 Mycophenolate mofetil 100 in 1 BOTTLE, PLASTIC CAPSULE 100 19 64380-726-07 Mycophenolate mofetil 500 in 1 BOTTLE, PLASTIC CAPSULE 500 19 64380-726-11 Mycophenolate mofetil 120 in 1 BOTTLE, PLASTIC CAPSULE 120 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MYCOPHENOLATE MOFETIL ACTIVE INGREDIENT 9242ECW6R0 MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED] 5 MYCOPHENOLIC ACID ACTIVE MOIETY HU9DX48N0T MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED] 5 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED] 5 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED] 5 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED] 5 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED] 5 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED] 5 GELATIN INACTIVE INGREDIENT 2G86QN327L MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED] 5 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED] 5 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES ARCOLAB LIMITED] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-726 MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [STRIDES PHARMA SCIENCE LIMITED] 17 Current NDC, Legacy NDC, 3 package rows 20250516_32dd890a-cfe3-4129-bce6-1d3dbe38e4f3.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mycophenolate mofetil MYCOPHENOLATE MOFETIL REMEDYREPACK INC. 77a75d5b-a90d-4ee5-aa8a-6da97d130357 2026-06-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090055 application number: ANDA090055 Mycophenolate mofetil MYCOPHENOLATE MOFETIL Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 3ac54299-15cc-4c7a-8831-60c15a859b85 2025-12-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090055 application number: ANDA090055 Mycophenolate mofetil MYCOPHENOLATE MOFETIL Strides Pharma Science Limited 32dd890a-cfe3-4129-bce6-1d3dbe38e4f3 2025-12-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090055 application number: ANDA090055 ndc (product): 64380-726 Mycophenolate mofetil MYCOPHENOLATE MOFETIL AvKARE 339a10c4-e442-de9e-e063-6294a90a6208 2025-04-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090055 application number: ANDA090055
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 64380-726-06 64380072606 100 CAPSULE in 1 BOTTLE, PLASTIC (64380-726-06) 100 capsule 2010-11-06 0000-00-00 No No Current 64380-726-07 64380072607 500 CAPSULE in 1 BOTTLE, PLASTIC (64380-726-07) 500 capsule 2010-11-06 0000-00-00 No No Current 64380-726-11 64380072611 120 CAPSULE in 1 BOTTLE, PLASTIC (64380-726-11) 120 capsule 2010-11-06 0000-00-00 No No Current