Home NDC 83270-000 mycophenolate mofetil
Product NDC 83270-000
11-digit product format 832700000
Labeler code 83270
Product ID 83270-000_42ed2be4-bc3d-281a-e063-6394a90aeb7f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mycophenolate mofetil
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler ONESOURCE SPECIALTY PHARMA LIMITED
Application ANDA216390
Marketing category ANDA
Marketing start 2023-04-30
Substance MYCOPHENOLATE MOFETIL
Active strength 500 mg/20mL
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 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216390-001 AP
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 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216390-001 MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500MG/VIAL INJECTABLE / INJECTION AP 2022-12-23 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base mycophenolate mofetil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MYCOPHENOLATE MOFETIL 500 mg/20mL
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 311881 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 83270-000-04 mycophenolate mofetil 4 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 4 7 83270-000-04 mycophenolate mofetil 20 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 20 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83270-000 MYCOPHENOLATE MOFETIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONESOURCE SPECIALTY PHARMA LIMITED] 6 Current NDC, 2 package rows 20250523_461a252f-ff81-4e08-b256-a497b14835fa.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83270-000-04 83270000004 4 VIAL in 1 CARTON (83270-000-04) / 20 mL in 1 VIAL 4 vial 2023-04-30 No No Current