Home NDC 83368-075 Ryzumvi
Product NDC 83368-075
11-digit product format 833680075
Labeler code 83368
Product ID 83368-075_5e9951e1-0574-4892-9aee-4909182153ad
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 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 · 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 · 13 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 12721810 2034-01-31 Drug product 2026-09-23 N217064-001 12734126 2034-01-31 U-4604 2026-09-23 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 2026-10-15 13:18:30 2026-09 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217064-001 RYZUMVI EQ 0.75% BASE SOLUTION / OPHTHALMIC RLD, RS 2023-09-25 caaa826d4ba7…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 4 · 154 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 N217064-001 10278918 2034-01-31 Drug product 2024-02-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217064-001 10772829 2034-01-31 Drug product 2024-02-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217064-001 11090261 2034-01-31 Drug product 2024-02-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217064-001 11844858 2034-01-31 Drug product 2024-01-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217064-001 12350366 2034-01-31 Drug product 2025-07-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217064-001 12721810 2034-01-31 Drug product 2026-09-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217064-001 12734126 2034-01-31 U-4604 2026-09-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217064-001 9795560 2034-01-31 Drug product 2024-02-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217064-001 11400077 2039-10-25 U-3804 2024-02-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217064-001 12201615 2039-10-25 U-3804 2025-01-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217064-001 12201616 2039-10-25 U-3804 2025-01-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217064-001 12576066 2039-10-25 U-3804 2026-04-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217064-001 12576067 2039-10-25 U-3804 2026-04-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 N217064-001 10278918 2034-01-31 Drug product 2024-02-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217064-001 10772829 2034-01-31 Drug product 2024-02-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217064-001 11090261 2034-01-31 Drug product 2024-02-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217064-001 11844858 2034-01-31 Drug product 2024-01-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217064-001 12350366 2034-01-31 Drug product 2025-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217064-001 9795560 2034-01-31 Drug product 2024-02-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217064-001 11400077 2039-10-25 U-3804 2024-02-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217064-001 12201615 2039-10-25 U-3804 2025-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217064-001 12201616 2039-10-25 U-3804 2025-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217064-001 12576066 2039-10-25 U-3804 2026-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217064-001 12576067 2039-10-25 U-3804 2026-04-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217064-001 10278918 2034-01-31 Drug product 2024-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217064-001 10772829 2034-01-31 Drug product 2024-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217064-001 11090261 2034-01-31 Drug product 2024-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217064-001 11844858 2034-01-31 Drug product 2024-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217064-001 12350366 2034-01-31 Drug product 2025-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217064-001 9795560 2034-01-31 Drug product 2024-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217064-001 11400077 2039-10-25 U-3804 2024-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217064-001 12201615 2039-10-25 U-3804 2025-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217064-001 12201616 2039-10-25 U-3804 2025-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217064-001 12576066 2039-10-25 U-3804 2026-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217064-001 12576067 2039-10-25 U-3804 2026-04-14 caaa826d4ba7…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…
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 Ryzumvi
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENTOLAMINE MESYLATE 10 mg/mL
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
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 / .2 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 / .2 mL in 1 VIAL, SINGLE-USE 1 pouch 2024-09-25 Yes No Current