Home NDC 85766-281 UBRELVY
Product NDC 85766-281
11-digit product format 857660281
Labeler code 85766
Product ID 85766-281_5c9c060b-9786-1c4d-e063-6294a90a788e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ubrogepant
Dosage form TABLET
Route ORAL
Labeler Sportpharm LLC
Application NDA211765
Marketing category NDA
Marketing start 2019-12-23
Substance UBROGEPANT
Active strength 100 mg/1
Pharmacologic classes Calcitonin Gene-related Peptide Receptor Antagonist [EPC], Calcitonin Gene-related Peptide Receptor Antagonists [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 43 .
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 N211765-001 UBRELVY UBROGEPANT 50MG TABLET / ORAL RLD 2019-12-23 N211765-002 UBRELVY UBROGEPANT 100MG TABLET / ORAL RLD, RS 2019-12-23
Orange Book patents# Current patent rows page 1 of 1 · 28 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211765-001 9499545 2031-11-10 U-2718 Drug substance, Drug product 2020-01-21 N211765-001 9833448 2031-11-10 U-2718 2020-01-21 N211765-001 8754096 2032-07-19 U-2717 Drug substance, Drug product 2020-01-21 N211765-001 8912210 2033-12-23 Drug substance, Drug product 2020-01-21 N211765-001 10117836 2035-01-30 Drug product 2020-01-21 N211765-001 11925709 2035-01-30 Drug product 2024-04-10 N211765-001 12168004 2035-01-30 Drug product 2025-01-15 N211765-001 12220408 2035-01-30 Drug product 2025-03-12 N211765-001 12310953 2035-01-30 Drug product 2025-06-25 N211765-001 12458632 2035-01-30 Drug product 2025-11-04 N211765-001 12458633 2035-01-30 Drug product 2025-11-04 N211765-001 11717515 2041-12-22 U-3677 2023-09-07 N211765-001 11857542 2041-12-22 U-3786 2024-01-31 N211765-001 12194030 2041-12-22 U-4121 2025-02-11 N211765-001 12194030 2041-12-22 U-4122 2025-02-11 N211765-001 12329750 2041-12-22 U-4213 2025-07-16 N211765-002 9499545 2031-11-10 U-2718 Drug substance, Drug product 2020-01-21 N211765-002 9833448 2031-11-10 U-2718 2020-01-21 N211765-002 8754096 2032-07-19 U-2717 Drug substance, Drug product 2020-01-21 N211765-002 8912210 2033-12-23 Drug substance, Drug product 2020-01-21 N211765-002 10117836 2035-01-30 Drug product 2020-01-21 N211765-002 11925709 2035-01-30 Drug product 2024-04-10 N211765-002 12168004 2035-01-30 Drug product 2025-01-15 N211765-002 12220408 2035-01-30 Drug product 2025-03-12 N211765-002 12310953 2035-01-30 Drug product 2025-06-25 N211765-002 12458632 2035-01-30 Drug product 2025-11-04 N211765-002 12458633 2035-01-30 Drug product 2025-11-04 N211765-002 12070450 2041-12-22 U-3992 2024-09-25
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 2 · 78 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 2026-09-14 22:38:34 2026-08 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N211765-001 UBRELVY 50MG TABLET / ORAL RLD 2019-12-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N211765-002 UBRELVY 100MG TABLET / ORAL RLD, RS 2019-12-23 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 14 · 559 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N211765-001 9499545 2031-11-10 U-2718 Drug substance, Drug product 2020-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 9833448 2031-11-10 U-2718 2020-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 8754096 2032-07-19 U-2717 Drug substance, Drug product 2020-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 8912210 2033-12-23 Drug substance, Drug product 2020-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 10117836 2035-01-30 Drug product 2020-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 11925709 2035-01-30 Drug product 2024-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 12168004 2035-01-30 Drug product 2025-01-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 12220408 2035-01-30 Drug product 2025-03-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 12310953 2035-01-30 Drug product 2025-06-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 12458632 2035-01-30 Drug product 2025-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 12458633 2035-01-30 Drug product 2025-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 11717515 2041-12-22 U-3677 2023-09-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 11857542 2041-12-22 U-3786 2024-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 12194030 2041-12-22 U-4121 2025-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 12194030 2041-12-22 U-4122 2025-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-001 12329750 2041-12-22 U-4213 2025-07-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-002 9499545 2031-11-10 U-2718 Drug substance, Drug product 2020-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-002 9833448 2031-11-10 U-2718 2020-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-002 8754096 2032-07-19 U-2717 Drug substance, Drug product 2020-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-002 8912210 2033-12-23 Drug substance, Drug product 2020-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-002 10117836 2035-01-30 Drug product 2020-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-002 11925709 2035-01-30 Drug product 2024-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-002 12168004 2035-01-30 Drug product 2025-01-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-002 12220408 2035-01-30 Drug product 2025-03-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-002 12310953 2035-01-30 Drug product 2025-06-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-002 12458632 2035-01-30 Drug product 2025-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-002 12458633 2035-01-30 Drug product 2025-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211765-002 12070450 2041-12-22 U-3992 2024-09-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211765-001 9499545 2031-11-10 U-2718 Drug substance, Drug product 2020-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211765-001 9833448 2031-11-10 U-2718 2020-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211765-001 8754096 2032-07-19 U-2717 Drug substance, Drug product 2020-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211765-001 8912210 2033-12-23 Drug substance, Drug product 2020-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211765-001 10117836 2035-01-30 Drug product 2020-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211765-001 11925709 2035-01-30 Drug product 2024-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211765-001 12168004 2035-01-30 Drug product 2025-01-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211765-001 12220408 2035-01-30 Drug product 2025-03-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211765-001 12310953 2035-01-30 Drug product 2025-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211765-001 12458632 2035-01-30 Drug product 2025-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211765-001 12458633 2035-01-30 Drug product 2025-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211765-001 11717515 2041-12-22 U-3677 2023-09-07 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 62 observed states.
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 UBRELVY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UBROGEPANT 100 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85766-281-01 85766028101 1 PACKET in 1 BOX (85766-281-01) / 1 TABLET in 1 PACKET 1 packet 2026-09-29 No No Current 85766-281-10 85766028110 10 PACKET in 1 BOX (85766-281-10) / 1 TABLET in 1 PACKET 10 packet 2026-09-29 No No Current 85766-281-16 85766028116 16 PACKET in 1 BOX (85766-281-16) / 1 TABLET in 1 PACKET 16 packet 2026-09-29 No No Current 85766-281-30 85766028130 30 PACKET in 1 BOX (85766-281-30) / 1 TABLET in 1 PACKET 30 packet 2026-09-29 No No Current