Home NDC 70518-3799 Mycophenolate mofetil
Product NDC 70518-3799
11-digit product format 705183799
Labeler code 70518
Product ID 70518-3799_3b2912ad-1721-3d82-e063-6394a90ad4fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mycophenolate mofetil
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA090055
Marketing category ANDA
Marketing start 2023-07-18
Marketing end 2027-12-31
Substance MYCOPHENOLATE MOFETIL
Active strength 250 mg/1
Pharmacologic classes Antimetabolite Immunosuppressant [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 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 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 70518-3799-0 Mycophenolate mofetil 100 in 1 BOX CAPSULE 100 4 70518-3799-1 Mycophenolate mofetil 1 in 1 POUCH CAPSULE 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-3799 MYCOPHENOLATE MOFETIL CAPSULE [REMEDYREPACK INC.] 3 Current NDC, 2 package rows 20241127_77a75d5b-a90d-4ee5-aa8a-6da97d130357.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 ndc (product): 70518-3799 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 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 70518-3799-0 70518379900 100 POUCH in 1 BOX (70518-3799-0) / 1 CAPSULE in 1 POUCH (70518-3799-1) 100 pouch 2023-07-18 2027-12-31 No No Historical 70518-3799-1 70518379901 1 in 1 POUCH Historical