Home NDC 67457-386 Mycophenolate Mofetil
Product NDC 67457-386
11-digit product format 674570386
Labeler code 67457
Product ID 67457-386_4c643876-2577-4197-ac9b-81bab65d1362
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mycophenolate Mofetil
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA203859
Marketing category ANDA
Marketing start 2021-01-26
Substance MYCOPHENOLATE MOFETIL
Active strength 500 mg/20mL
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 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203859-001 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 · 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 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203859-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2017-03-31 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 500 mg/20mL
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 311881 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 67457-386-00 Mycophenolate Mofetil 20 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 20 5 67457-386-81 Mycophenolate Mofetil 4 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 4 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-386 MYCOPHENOLATE MOFETIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 4 Current NDC, Legacy NDC, 2 package rows 20230105_da02b428-42a4-4007-b0b7-695f2db010f2.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 67457-386-00 67457038600 20 mL in 1 VIAL 20 ml Historical 67457-386-81 67457038681 4 VIAL in 1 CARTON (67457-386-81) / 20 mL in 1 VIAL (67457-386-00) 4 vial 2021-01-26 0000-00-00 No No Current