Home NDC 33342-351 Dimethyl Fumarate
Product NDC 33342-351
11-digit product format 333420351
Labeler code 33342
Product ID 33342-351_ef3e9cf5-b172-4e67-b621-dc94e9e9d93f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dimethyl Fumarate
Dosage form KIT
Labeler Macleods Pharmaceuticals Limited
Application ANDA210377
Marketing category ANDA
Marketing start 2024-06-26
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210377-001 DIMETHYL FUMARATE DIMETHYL FUMARATE 120MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 A210377-002 DIMETHYL FUMARATE DIMETHYL FUMARATE 240MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A210377-001 DIMETHYL FUMARATE 120MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210377-002 DIMETHYL FUMARATE 240MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210377-001 DIMETHYL FUMARATE 120MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210377-002 DIMETHYL FUMARATE 240MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210377-001 DIMETHYL FUMARATE 120MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210377-002 DIMETHYL FUMARATE 240MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210377-001 DIMETHYL FUMARATE 120MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210377-002 DIMETHYL FUMARATE 240MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210377-001 DIMETHYL FUMARATE 120MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210377-002 DIMETHYL FUMARATE 240MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210377-001 DIMETHYL FUMARATE 120MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210377-002 DIMETHYL FUMARATE 240MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210377-001 DIMETHYL FUMARATE 120MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210377-002 DIMETHYL FUMARATE 240MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210377-001 DIMETHYL FUMARATE 120MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210377-002 DIMETHYL FUMARATE 240MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210377-001 DIMETHYL FUMARATE 120MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210377-002 DIMETHYL FUMARATE 240MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210377-001 DIMETHYL FUMARATE 120MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210377-002 DIMETHYL FUMARATE 240MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210377-001 DIMETHYL FUMARATE 120MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210377-002 DIMETHYL FUMARATE 240MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210377-001 DIMETHYL FUMARATE 120MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210377-002 DIMETHYL FUMARATE 240MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210377-001 DIMETHYL FUMARATE 120MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210377-002 DIMETHYL FUMARATE 240MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210377-001 DIMETHYL FUMARATE 120MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210377-002 DIMETHYL FUMARATE 240MG CAPSULE, DELAYED RELEASE / ORAL AB 2024-06-26 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Dimethyl Fumarate
Listing expiration 2026-12-31 Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FO2303MNI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1373483 Internal RxNorm lookup 1373491 Internal RxNorm lookup 1373497 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 33342-349-91 Dimethyl Fumarate 14 in 1 BLISTER PACK CAPSULE, DELAYED RELEASE 14 120 mg 2 33342-350-92 Dimethyl Fumarate 23 in 1 BLISTER PACK CAPSULE, DELAYED RELEASE 46 240 mg 2 33342-351-93 Dimethyl Fumarate 1 in 1 KIT KIT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-351 DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE DIMETHYL FUMARATE KIT [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 3 package rows 20240716_f8ada3e3-55c0-43e3-95b9-c6d11ffc42dd.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 Units Marketing start Sample Exclude flag Status 33342-349-91 33342034991 14 in 1 BLISTER PACK Historical 33342-350-92 33342035092 23 in 1 BLISTER PACK Historical 33342-351-93 33342035193 1 KIT in 1 KIT (33342-351-93) * 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (33342-349-91) * 23 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (33342-350-92) 1 kit 2024-06-26 No No Current