Home NDC 70752-294 Mycophenolate Mofetil
Product NDC 70752-294
11-digit product format 707520294
Labeler code 70752
Product ID 70752-294_215ded5d-6271-4568-af2b-75e5f21501ba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mycophenolate Mofetil
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler QUAGEN PHARMACEUTICALS LLC
Application ANDA214525
Marketing category ANDA
Marketing start 2026-08-06
Substance MYCOPHENOLATE MOFETIL
Active strength 200 mg/mL
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 43 .
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 A214525-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214525-001 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.
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 2026-09-14 22:38:34 2026-08 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214525-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2021-07-29 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 200 mg/mL
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 311880 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70752-294-60 70752029460 1 BOTTLE, PLASTIC in 1 CARTON (70752-294-60) / 225 mL in 1 BOTTLE, PLASTIC 2026-08-06 No No Current