Home NDC 50090-8038 RIZAFILM
Product NDC 50090-8038
11-digit product format 500908038
Labeler code 50090
Product ID 50090-8038_07cd6b0a-291d-4a45-8f01-a2d68239623c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rizatriptan benzoate
Dosage form FILM
Route ORAL
Labeler A-S Medication Solutions
Application NDA205394
Marketing category NDA
Marketing start 2026-04-27
Substance RIZATRIPTAN BENZOATE
Active strength 10 mg/1
Pharmacologic classes Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
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 N205394-001 RIZAFILM RIZATRIPTAN BENZOATE EQ 10MG BASE FILM / ORAL RLD 2023-04-14 N205394-002 RIZAFILM RIZATRIPTAN BENZOATE EQ 5MG BASE FILM / ORAL RLD 2026-02-26
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26
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 2026-09-14 22:38:34 2026-08 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD 2023-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205394-002 RIZAFILM EQ 5MG BASE FILM / ORAL RLD 2026-02-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD 2023-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205394-002 RIZAFILM EQ 5MG BASE FILM / ORAL RLD 2026-02-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD 2023-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD 2023-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD 2023-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD 2023-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD 2023-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD 2023-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD 2023-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD 2023-04-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD 2023-04-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD 2023-04-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD 2023-04-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD 2023-04-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD, RS 2023-04-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD, RS 2023-04-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD, RS 2023-04-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD, RS 2023-04-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD, RS 2023-04-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD, RS 2023-04-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD, RS 2023-04-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD, RS 2023-04-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD, RS 2023-04-14 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N205394-001 RIZAFILM EQ 10MG BASE FILM / ORAL RLD 2023-04-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N205394-002 RIZAFILM EQ 5MG BASE FILM / ORAL RLD, RS 2026-02-26 a50c72e98297…
Observed Orange Book patent history# 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 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N205394-001 9301948 2034-07-30 Drug substance, Drug product 2023-07-26 a50c72e98297…
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 RIZAFILM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIZATRIPTAN BENZOATE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WR978S7QHH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2634482 Internal RxNorm lookup 2672955 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-8038-0 50090803800 3 FILM in 1 BOTTLE (50090-8038-0) 3 film 2026-08-26 No No Current 50090-8038-1 50090803801 9 FILM in 1 BOTTLE (50090-8038-1) 9 film 2026-08-26 No No Current