Home NDC 60429-070 Mycophenolate Mofetil
Product NDC 60429-070
11-digit product format 604290070
Labeler code 60429
Product ID 60429-070_eb6968a1-7970-3caa-e053-2995a90ae6af
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mycophenolate mofetil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA065521
Marketing category ANDA
Marketing start 2009-05-04
Marketing end 0000-00-00
Substance MYCOPHENOLATE MOFETIL
Active strength 500 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 A065521-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 500MG TABLET / 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 1 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 2026-08-18 06:07:40 2026-07 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL 2009-05-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065521-001 MYCOPHENOLATE MOFETIL 500MG TABLET / ORAL AB 2009-05-04 e64feba35796…
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 60429-070 MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 11 Legacy NDC 20240724_1546c504-adfb-453c-a682-8e41888e8b4e.zip
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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 60429-070-01 60429007001 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-070-01) 2015-01-06 0000-00-00 No No Current 60429-070-05 60429007005 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-070-05) 2015-01-06 0000-00-00 No No Current