Home NDC 27505-110 Xadago
Product NDC 27505-110
11-digit product format 275050110
Labeler code 27505
Product ID 27505-110_41c1c50d-7460-15f0-e063-6294a90a1b79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name safinamide mesylate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.
Application NDA207145
Marketing category NDA
Marketing start 2017-05-08
Substance SAFINAMIDE MESYLATE
Active strength 50 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207145-001 XADAGO SAFINAMIDE MESYLATE EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 N207145-002 XADAGO SAFINAMIDE MESYLATE EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 N207145-002 8283380 2031-03-21 U-1993 2017-04-20
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 · 82 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 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL RLD 2017-03-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL RLD, RS 2017-03-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL RLD 2017-03-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL RLD, RS 2017-03-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL RLD 2017-03-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL RLD, RS 2017-03-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207145-001 XADAGO 50MG TABLET / ORAL RLD 2017-03-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207145-002 XADAGO 100MG TABLET / ORAL RLD, RS 2017-03-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL RLD 2017-03-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL RLD, RS 2017-03-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL RLD 2017-03-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL RLD, RS 2017-03-21 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 7 · 246 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207145-002 8283380 2031-03-21 U-1993 2017-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207145-002 8283380 2031-03-21 U-1993 2017-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207145-002 8283380 2031-03-21 U-1993 2017-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207145-002 8283380 2031-03-21 U-1993 2017-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207145-002 8283380 2031-03-21 U-1993 2017-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207145-002 8283380 2031-03-21 U-1993 2017-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 2680178bc6a6…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Xadago
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SAFINAMIDE MESYLATE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YS90V3DTX0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1922466 Internal RxNorm lookup 1922472 Internal RxNorm lookup 1922474 Internal RxNorm lookup 1922476 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 27505-110-14 Xadago 14 in 1 BLISTER PACK TABLET, FILM COATED 14 20 27505-110-14 Xadago 1 in 1 CARTON TABLET, FILM COATED 1 20 27505-110-30 Xadago 1 in 1 CARTON TABLET, FILM COATED 1 20 27505-110-30 Xadago 30 in 1 BOTTLE TABLET, FILM COATED 30 20 27505-110-90 Xadago 90 in 1 BOTTLE TABLET, FILM COATED 90 20 27505-110-90 Xadago 1 in 1 CARTON TABLET, FILM COATED 1 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27505-110 XADAGO (SAFINAMIDE MESYLATE) TABLET, FILM COATED [MDD US OPERATIONS LLC, A SUBSIDIARY OF SUPERNUS PHARMACEUTICALS, INC.] 17 Current NDC, Legacy NDC, 6 package rows 20241012_c4d65f28-983f-42b4-bb23-023ae0fe81b2.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Xadago SAFINAMIDE MESYLATE MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. c4d65f28-983f-42b4-bb23-023ae0fe81b2 2025-10-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 207145 application number: NDA207145 ndc (product): 27505-110
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 27505-110-14 27505011014 1 BLISTER PACK in 1 CARTON (27505-110-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2017-05-08 0000-00-00 No No Current 27505-110-30 27505011030 1 BOTTLE in 1 CARTON (27505-110-30) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2017-05-08 0000-00-00 No No Current 27505-110-90 27505011090 1 BOTTLE in 1 CARTON (27505-110-90) / 90 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2017-05-08 0000-00-00 No No Current