Home NDC 67877-225 Mycophenolate Mofetil
Product NDC 67877-225
11-digit product format 678770225
Labeler code 67877
Product ID 67877-225_f8b5a092-55fd-4e91-aa56-98fe69f1c091
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mycophenolate Mofetil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA091249
Marketing category ANDA
Marketing start 2011-11-28
Substance MYCOPHENOLATE MOFETIL
Active strength 500 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 A091249-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091249-001 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 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091249-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2011-11-04 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 500 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 67877-225-01 Mycophenolate Mofetil 100 in 1 BOTTLE TABLET, FILM COATED 100 36 67877-225-05 Mycophenolate Mofetil 500 in 1 BOTTLE TABLET, FILM COATED 500 36 67877-225-38 Mycophenolate Mofetil 10 in 1 CARTON TABLET, FILM COATED 10 36 67877-225-38 Mycophenolate Mofetil 10 in 1 BLISTER PACK TABLET, FILM COATED 10 36 67877-225-84 Mycophenolate Mofetil 10 in 1 BLISTER PACK TABLET, FILM COATED 10 36 67877-225-84 Mycophenolate Mofetil 3 in 1 CARTON TABLET, FILM COATED 3 36
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 [ASCEND LABORATORIES, LLC] 15 MYCOPHENOLIC ACID ACTIVE MOIETY HU9DX48N0T MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15 GELATIN INACTIVE INGREDIENT 2G86QN327L MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15 POVIDONE INACTIVE INGREDIENT FZ989GH94E MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15 POVIDONE K90 INACTIVE INGREDIENT RDH86HJV5Z MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-225 MYCOPHENOLATE MOFETIL TABLET, FILM COATED MYCOPHENOLATE MOFETIL CAPSULE [ASCEND LABORATORIES, LLC] 33 Current NDC, Legacy NDC, 6 package rows 20240823_9f84ea84-2d8b-4d91-a33f-7dfb5df937dc.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 · 3 matching rows.
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 67877-225-01 67877022501 100 TABLET, FILM COATED in 1 BOTTLE (67877-225-01) 2011-11-28 0000-00-00 No No Current 67877-225-05 67877022505 500 TABLET, FILM COATED in 1 BOTTLE (67877-225-05) 2011-11-28 0000-00-00 No No Current 67877-225-38 67877022538 10 BLISTER PACK in 1 CARTON (67877-225-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2011-11-28 0000-00-00 No No Current 67877-225-84 67877022584 3 BLISTER PACK in 1 CARTON (67877-225-84) / 10 TABLET, FILM COATED in 1 BLISTER PACK 3 blister pack 2011-11-28 0000-00-00 No No Current