Home NDC 83368-075 Ryzumvi
Product NDC 83368-075
11-digit product format 833680075
Labeler code 83368
Product ID 83368-075_7f954669-af25-4d50-8430-36dcc77fd78f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name phentolamine mesylate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Oyster Point Pharma, Inc.
Application NDA217064
Marketing category NDA
Marketing start 2024-03-25
Substance PHENTOLAMINE MESYLATE
Active strength 10 mg/mL
Pharmacologic classes Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217064-001 RYZUMVI PHENTOLAMINE MESYLATE EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25
Orange Book patents# Current patent rows page 1 of 1 · 11 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217064-001 10278918 2034-01-31 Drug product 2024-02-01 N217064-001 10772829 2034-01-31 Drug product 2024-02-01 N217064-001 11090261 2034-01-31 Drug product 2024-02-01 N217064-001 11844858 2034-01-31 Drug product 2024-01-18 N217064-001 12350366 2034-01-31 Drug product 2025-07-30 N217064-001 9795560 2034-01-31 Drug product 2024-02-01 N217064-001 11400077 2039-10-25 U-3804 2024-02-01 N217064-001 12201615 2039-10-25 U-3804 2025-01-27 N217064-001 12201616 2039-10-25 U-3804 2025-01-27 N217064-001 12576066 2039-10-25 U-3804 2026-04-14 N217064-001 12576067 2039-10-25 U-3804 2026-04-14
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217064-001 NP 2026-09-25
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.
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 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 119 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 N217064-001 10278918 2034-01-31 Drug product 2024-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217064-001 10772829 2034-01-31 Drug product 2024-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217064-001 11090261 2034-01-31 Drug product 2024-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217064-001 11844858 2034-01-31 Drug product 2024-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217064-001 12350366 2034-01-31 Drug product 2025-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217064-001 9795560 2034-01-31 Drug product 2024-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217064-001 11400077 2039-10-25 U-3804 2024-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217064-001 12201616 2039-10-25 U-3804 2025-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217064-001 12201615 2039-12-25 U-3804 2025-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217064-001 10278918 2034-01-31 Drug product 2024-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217064-001 10772829 2034-01-31 Drug product 2024-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217064-001 11090261 2034-01-31 Drug product 2024-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217064-001 11844858 2034-01-31 Drug product 2024-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217064-001 12350366 2034-01-31 Drug product 2025-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217064-001 9795560 2034-01-31 Drug product 2024-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217064-001 11400077 2039-10-25 U-3804 2024-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217064-001 12201616 2039-10-25 U-3804 2025-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217064-001 12201615 2039-12-25 U-3804 2025-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217064-001 10278918 2034-01-31 Drug product 2024-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217064-001 10772829 2034-01-31 Drug product 2024-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217064-001 11090261 2034-01-31 Drug product 2024-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217064-001 11844858 2034-01-31 Drug product 2024-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217064-001 12350366 2034-01-31 Drug product 2025-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217064-001 9795560 2034-01-31 Drug product 2024-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217064-001 11400077 2039-10-25 U-3804 2024-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217064-001 12201616 2039-10-25 U-3804 2025-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217064-001 12201615 2039-12-25 U-3804 2025-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217064-001 10278918 2034-01-31 Drug product 2024-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217064-001 10772829 2034-01-31 Drug product 2024-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217064-001 11090261 2034-01-31 Drug product 2024-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217064-001 11844858 2034-01-31 Drug product 2024-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217064-001 9795560 2034-01-31 Drug product 2024-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217064-001 11400077 2039-10-25 U-3804 2024-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217064-001 12201616 2039-10-25 U-3804 2025-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217064-001 12201615 2039-12-25 U-3804 2025-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217064-001 10278918 2034-01-31 Drug product 2024-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217064-001 10772829 2034-01-31 Drug product 2024-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217064-001 11090261 2034-01-31 Drug product 2024-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217064-001 11844858 2034-01-31 Drug product 2024-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217064-001 9795560 2034-01-31 Drug product 2024-02-01 b8a1b40f171c…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Ryzumvi
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENTOLAMINE MESYLATE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Y7543E5K9T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2677793 Internal RxNorm lookup 2677798 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 83368-075-30 Ryzumvi 6 in 1 CARTON SOLUTION/ DROPS 6 4 83368-075-30 Ryzumvi 5 in 1 POUCH SOLUTION/ DROPS 5 4 83368-075-31 Ryzumvi 5 in 1 POUCH SOLUTION/ DROPS 5 4 83368-075-31 Ryzumvi 1 in 1 CARTON SOLUTION/ DROPS 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83368-075 RYZUMVI (PHENTOLAMINE MESYLATE) SOLUTION/ DROPS [OYSTER POINT PHARMA, INC.] 4 Current NDC, 4 package rows 20241123_96bb1e53-c2cc-4e60-a21a-db0269c371bf.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 Ryzumvi PHENTOLAMINE MESYLATE Oyster Point Pharma, Inc. 96bb1e53-c2cc-4e60-a21a-db0269c371bf 2026-03-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 217064 application number: NDA217064 ndc (product): 83368-075
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83368-075-30 83368007530 6 POUCH in 1 CARTON (83368-075-30) / 5 VIAL, SINGLE-USE in 1 POUCH / .31 mL in 1 VIAL, SINGLE-USE 6 pouch 2024-03-25 No No Current 83368-075-31 83368007531 1 POUCH in 1 CARTON (83368-075-31) / 5 VIAL, SINGLE-USE in 1 POUCH / .31 mL in 1 VIAL, SINGLE-USE 1 pouch 2024-09-25 Yes No Current