Home NDC 67877-230 Mycophenolate mofetil
Product NDC 67877-230
11-digit product format 678770230
Labeler code 67877
Product ID 67877-230_d57b5ef3-52b0-473c-aa54-3208566e5909
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mycophenolate mofetil
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA203005
Marketing category ANDA
Marketing start 2014-11-17
Substance MYCOPHENOLATE MOFETIL
Active strength 200 mg/mL
Pharmacologic classes Antimetabolite Immunosuppressant [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 A203005-001 MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203005-001 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.
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 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML SUSPENSION / ORAL AB 2014-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML SUSPENSION / ORAL AB 2014-11-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML SUSPENSION / ORAL AB 2014-11-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML SUSPENSION / ORAL AB 2014-11-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML SUSPENSION / ORAL AB 2014-11-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML SUSPENSION / ORAL AB 2014-11-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML SUSPENSION / ORAL AB 2014-11-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML SUSPENSION / ORAL AB 2014-11-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203005-001 MYCOPHENOLATE MOFETIL 200MG/ML FOR SUSPENSION / ORAL AB 2014-11-14 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 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 67877-230-22 Mycophenolate mofetil 1 in 1 CARTON POWDER, FOR SUSPENSION 1 30 67877-230-22 Mycophenolate mofetil 225 mL in 1 BOTTLE, PLASTIC POWDER, FOR SUSPENSION 225 30
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MYCOPHENOLATE MOFETIL ACTIVE INGREDIENT 9242ECW6R0 MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] 10 MYCOPHENOLIC ACID ACTIVE MOIETY HU9DX48N0T MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] 10 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] 10 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] 10 FRUIT, UNSPECIFIED INACTIVE INGREDIENT C2AIY4ERZC MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] 10 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] 10 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] 10 SORBITOL INACTIVE INGREDIENT 506T60A25R MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] 10 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] 10 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-230 MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC] 27 Current NDC, Legacy NDC, 2 package rows 20240216_21ff53b0-b4ba-4473-91e4-76ef41681064.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 67877-230-22 67877023022 1 BOTTLE, PLASTIC in 1 CARTON (67877-230-22) / 225 mL in 1 BOTTLE, PLASTIC 2014-11-17 0000-00-00 No No Current