Home NDC 71610-033 Mycophenolate Mofetil
Product NDC 71610-033
11-digit product format 716100033
Labeler code 71610
Product ID 71610-033_11d3eb0d-489b-06c5-e063-6294a90a9d3b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mycophenolate mofetil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA065521
Marketing category ANDA
Marketing start 2015-01-06
Substance MYCOPHENOLATE MOFETIL
Active strength 500 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 A065521-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL 2009-05-04
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 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL 2009-05-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 e64feba35796…
Observed Orange Book normalized TE history# 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/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 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 71610-033-53 Mycophenolate Mofetil 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 2 71610-033-60 Mycophenolate Mofetil 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 2 71610-033-70 Mycophenolate Mofetil 120 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 120 2 71610-033-80 Mycophenolate Mofetil 180 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 180 2 71610-033-90 Mycophenolate Mofetil 240 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 240 2 71610-033-92 Mycophenolate Mofetil 270 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 270 2 71610-033-98 Mycophenolate Mofetil 540 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 540 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-033 MYCOPHENOLATE MOFETIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Current NDC, Legacy NDC, 7 package rows 20240221_721564bc-7c0b-4418-ab49-0af362e74eb7.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 Marketing start Marketing end Sample Exclude flag Status 71610-033-53 71610003353 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-53) 2019-07-01 No No Current 71610-033-60 71610003360 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-60) 2019-07-01 No No Current 71610-033-70 71610003370 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-70) 2018-01-19 0000-00-00 No No Current 71610-033-80 71610003380 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-80) 2019-07-01 No No Current 71610-033-90 71610003390 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-90) 2019-07-01 No No Current 71610-033-92 71610003392 270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-92) 2019-07-01 No No Current 71610-033-98 71610003398 540 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-98) 2019-07-01 No No Current