Home NDC 31722-879-01 Mycophenolate Mofetil
Product NDC 31722-879
Requested package NDC 31722-879-01
11-digit product format 317220879
Labeler code 31722
Product ID 31722-879_5ebb7856-5d51-954b-e063-6394a90aecfb
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 44 .
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 2026-10-15 13:18:30 2026-09 A208119-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2024-10-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A208119-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2024-10-22 84e616aacf4f…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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
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