Home NDC 60429-059 Mycophenolate Mofetil
Product NDC 60429-059
11-digit product format 604290059
Labeler code 60429
Product ID 60429-059_eb6968a1-7970-3caa-e053-2995a90ae6af
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mycophenolate mofetil
Dosage form CAPSULE
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA065520
Marketing category ANDA
Marketing start 2009-05-04
Marketing end 0000-00-00
Substance MYCOPHENOLATE MOFETIL
Active strength 250 mg/1
Pharmacologic classes Antimetabolite Immunosuppressant [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 A065520-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE / 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 2 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 2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065520-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL AB 2009-05-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A065520-001 MYCOPHENOLATE MOFETIL 250MG CAPSULE / ORAL 2009-05-04 a50c72e98297…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MYCOPHENOLATE MOFETIL ACTIVE INGREDIENT 9242ECW6R0 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 MYCOPHENOLIC ACID ACTIVE MOIETY HU9DX48N0T MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 AMMONIA INACTIVE INGREDIENT 5138Q19F1X MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60429-059 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 11 Legacy NDC 20240724_1546c504-adfb-453c-a682-8e41888e8b4e.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60429-059-01 60429005901 100 CAPSULE in 1 BOTTLE, PLASTIC (60429-059-01) 100 capsule 2015-01-06 0000-00-00 No No Current 60429-059-05 60429005905 500 CAPSULE in 1 BOTTLE, PLASTIC (60429-059-05) 500 capsule 2015-01-06 0000-00-00 No No Current