Home NDC 0093-7334 Mycophenolate Mofetil
Product NDC 0093-7334
11-digit product format 000937334
Labeler code 0093
Product ID 0093-7334_d924ecfe-fba4-41ad-a1c1-e8ee06d76e67
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mycophenolate Mofetil
Dosage form CAPSULE
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA065491
Marketing category ANDA
Marketing start 2009-05-06
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 A065491-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065491-001 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 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065491-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-06 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 2026-12-31 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 0093-7334-01 Mycophenolate Mofetil 100 in 1 BOTTLE CAPSULE 100 33 0093-7334-05 Mycophenolate Mofetil 500 in 1 BOTTLE CAPSULE 500 33
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MYCOPHENOLATE MOFETIL ACTIVE INGREDIENT 9242ECW6R0 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 MYCOPHENOLIC ACID ACTIVE MOIETY HU9DX48N0T MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 GELATIN INACTIVE INGREDIENT 2G86QN327L MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 SHELLAC INACTIVE INGREDIENT 46N107B71O MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 TALC INACTIVE INGREDIENT 7SEV7J4R1U MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-7334 MYCOPHENOLATE MOFETIL CAPSULE [TEVA PHARMACEUTICALS USA, INC.] 32 Current NDC, Legacy NDC, 2 package rows 20250502_b414303f-e6f3-4e22-a537-96be352b59a4.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.
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 0093-7334-01 00093733401 100 CAPSULE in 1 BOTTLE (0093-7334-01) 100 capsule 2009-05-06 0000-00-00 No No Current 0093-7334-05 00093733405 500 CAPSULE in 1 BOTTLE (0093-7334-05) 500 capsule 2009-05-06 0000-00-00 No No Current