Home NDC 68180-803 RUFINAMIDE
Product NDC 68180-803
11-digit product format 681800803
Labeler code 68180
Product ID 68180-803_3db88bc9-af10-4a67-86c5-9f034fa4db9a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rufinamide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA204964
Marketing category ANDA
Marketing start 2022-11-28
Substance RUFINAMIDE
Active strength 200 mg/1
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 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204964-001 RUFINAMIDE RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 A204964-002 RUFINAMIDE RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 A204964-003 RUFINAMIDE RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17
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.
Product history page 1 of 3 · 81 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 2026-02-19 14:30 UTC 2026-02 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204964-002 RUFINAMIDE 200MG TABLET / ORAL AB 2022-08-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204964-003 RUFINAMIDE 400MG TABLET / ORAL AB 2022-08-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204964-001 RUFINAMIDE 100MG TABLET / ORAL 2022-08-17 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
Additional Listing Data#
Finished product Yes
Brand name base RUFINAMIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RUFINAMIDE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WFW942PR79 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 824295 Internal RxNorm lookup 824301 Internal RxNorm lookup 2612668 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 68180-803-06 RUFINAMIDE 30 in 1 BOTTLE TABLET, FILM COATED 30 14 68180-803-16 RUFINAMIDE 120 in 1 BOTTLE TABLET, FILM COATED 120 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-803 RUFINAMIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 12 Current NDC, Legacy NDC, 2 package rows 20231208_2c2c8d41-1ae4-453a-b628-954ee0b3be5c.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 68180-803-06 68180080306 30 TABLET, FILM COATED in 1 BOTTLE (68180-803-06) 2022-10-01 0000-00-00 No No Current 68180-803-16 68180080316 120 TABLET, FILM COATED in 1 BOTTLE (68180-803-16) 2022-11-28 0000-00-00 No No Current