Home NDC 27505-111 Xadago
Product NDC 27505-111
11-digit product format 275050111
Labeler code 27505
Product ID 27505-111_5d1a8d01-8b05-c3b1-e063-6294a90a48ca
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 100 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 88 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 2026-10-15 13:18:30 2026-09 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207145-001 XADAGO EQ 50MG BASE TABLET / ORAL AB RLD 2017-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207145-002 XADAGO EQ 100MG BASE TABLET / ORAL AB RLD, RS 2017-03-21 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 7 · 264 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N207145-002 8283380 2031-03-21 U-1993 2017-04-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207145-002 8283380 2031-03-21 U-1993 2017-04-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207145-001 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207145-001 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207145-001 8283380 2031-03-21 U-1993 2017-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207145-002 8278485 2027-06-08 U-1993 Drug substance 2017-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207145-002 8076515 2028-12-10 U-1993 Drug substance, Drug product 2017-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207145-002 8283380 2031-03-21 U-1993 2017-04-20 caaa826d4ba7…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…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Xadago
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SAFINAMIDE MESYLATE 100 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 27505-111-14 Xadago 14 in 1 BLISTER PACK TABLET, FILM COATED 14 20 27505-111-14 Xadago 1 in 1 CARTON TABLET, FILM COATED 1 20 27505-111-30 Xadago 1 in 1 CARTON TABLET, FILM COATED 1 20 27505-111-30 Xadago 30 in 1 BOTTLE TABLET, FILM COATED 30 20 27505-111-90 Xadago 90 in 1 BOTTLE TABLET, FILM COATED 90 20 27505-111-90 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 27505-111 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
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 27505-111-14 27505011114 1 BLISTER PACK in 1 CARTON (27505-111-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2017-05-08 0000-00-00 No No Current 27505-111-30 27505011130 1 BOTTLE in 1 CARTON (27505-111-30) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2017-05-08 0000-00-00 No No Current 27505-111-90 27505011190 1 BOTTLE in 1 CARTON (27505-111-90) / 90 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2017-05-08 0000-00-00 No No Current