Home NDC 23155-848 MYCOPHENOLATE MOFETIL
Product NDC 23155-848
11-digit product format 231550848
Labeler code 23155
Product ID 23155-848_b5316b1d-ed7b-426d-9b86-dd17018c97a5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MYCOPHENOLATE MOFETIL
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application ANDA212634
Marketing category ANDA
Marketing start 2023-09-05
Marketing end 2028-02-29
Substance MYCOPHENOLATE MOFETIL
Active strength 200 mg/mL
Pharmacologic classes Antimetabolite Immunosuppressant [EPC]
NDC exclude flag No
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 A212634-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212634-001 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 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212634-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2023-08-29 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base MYCOPHENOLATE MOFETIL 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 23155-848-51 MYCOPHENOLATE MOFETIL 225 mL in 1 BOTTLE, PLASTIC POWDER, FOR SUSPENSION 225 2 23155-848-51 MYCOPHENOLATE MOFETIL 1 in 1 CARTON POWDER, FOR SUSPENSION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 23155-848 MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] 1 Current NDC, 2 package rows 20230905_df3ba2e9-00bb-40af-8658-2c5fd2e398ef.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 23155-848-51 23155084851 1 BOTTLE, PLASTIC in 1 CARTON (23155-848-51) / 225 mL in 1 BOTTLE, PLASTIC 2023-09-05 2028-02-29 No No Historical