Home NDC 31722-879 Mycophenolate Mofetil
Product NDC 31722-879
11-digit product format 317220879
Labeler code 31722
Product ID 31722-879_48432e06-b34c-4277-e063-6394a90a6ba0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mycophenolate Mofetil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA208119
Marketing category ANDA
Marketing start 2024-10-22
Substance MYCOPHENOLATE MOFETIL
Active strength 500 mg/1
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 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 A208119-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2024-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208119-001 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 A208119-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2024-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208119-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2024-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208119-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2024-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208119-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2024-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208119-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2024-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208119-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2024-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208119-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2024-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208119-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2024-10-22 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208119-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2024-10-22 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208119-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2024-10-22 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 31722-879-01 Mycophenolate Mofetil 100 in 1 BOTTLE TABLET, FILM COATED 100 2 31722-879-05 Mycophenolate Mofetil 500 in 1 BOTTLE TABLET, FILM COATED 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-879 MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 Current NDC, 2 package rows 20241109_c3ded171-89da-4644-9ee8-dbcf6258036f.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 Sample Exclude flag Status 31722-879-01 31722087901 100 TABLET, FILM COATED in 1 BOTTLE (31722-879-01) 2024-10-22 No No Current 31722-879-05 31722087905 500 TABLET, FILM COATED in 1 BOTTLE (31722-879-05) 2024-10-22 No No Current