Home NDC 59651-646 MYCOPHENOLATE MOFETIL
Product NDC 59651-646
11-digit product format 596510646
Labeler code 59651
Product ID 59651-646_83531645-459d-4746-bc46-2d32928e9417
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mycophenolate mofetil
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA218227
Marketing category ANDA
Marketing start 2024-09-26
Substance MYCOPHENOLATE MOFETIL
Active strength 200 mg/mL
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 A218227-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2024-09-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218227-001 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 2026-08-18 06:07:40 2026-07 A218227-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2024-09-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218227-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2024-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218227-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2024-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218227-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2024-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218227-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2024-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218227-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2024-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218227-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2024-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218227-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2024-09-26 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218227-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2024-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218227-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2024-09-26 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218227-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2024-09-26 a50c72e98297…
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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59651-646-26 MYCOPHENOLATE MOFETIL 1 in 1 CARTON POWDER, FOR SUSPENSION 1 2 59651-646-26 MYCOPHENOLATE MOFETIL 225 mL in 1 BOTTLE POWDER, FOR SUSPENSION 225 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-646 MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] 1 Current NDC, 2 package rows 20241008_20fa7709-a203-481f-aaf4-e98fab1acd0d.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-646-26 59651064626 1 BOTTLE in 1 CARTON (59651-646-26) / 225 mL in 1 BOTTLE 1 bottle 2024-09-26 No No Current