Home DailyMed 628d1ff3-94bc-44bf-9de9-d3d535e199dc MYCOPHENOLATE MOFETIL FOR INJECTION, USP Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Zydus Lifesciences Limited
Effective date 2023-10-03
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 7
Source legacy-cache
Hydrated at 2026-08-01 21:25:05 Label at a glance# Product Mycophenolate Mofetil
Active ingredient MYCOPHENOLATE MOFETIL
Label structure 1 sections
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1084 MYCOPHENOLATE MOFETIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED] 7 Legacy NDC 20231005_628d1ff3-94bc-44bf-9de9-d3d535e199dc.zip
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 7 matching rows.
Mycophenolate Mofetil MYCOPHENOLIC ACID POLYSORBATE 80 ANHYDROUS CITRIC ACID WATER HYDROCHLORIC ACID SODIUM HYDROXIDE Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 6 matching rows.
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204473-001 AP
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 · 44 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 2026-10-15 13:18:30 2026-09 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204473-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-08-31 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
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Matched openFDA labels page 1 of 1 · 1 matching rows.
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