ryzumvi

Generic: phentolamine mesylate

Labeler: oyster point pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ryzumvi
Generic Name phentolamine mesylate
Labeler oyster point pharma, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

phentolamine mesylate 10 mg/mL

Manufacturer
Oyster Point Pharma, Inc.

Identifiers & Regulatory

Product NDC 83368-075
Product ID 83368-075_7f954669-af25-4d50-8430-36dcc77fd78f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217064
Listing Expiration 2026-12-31
Marketing Start 2024-03-25

Pharmacologic Class

Classes
adrenergic alpha-antagonists [moa] alpha-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83368075
Hyphenated Format 83368-075

Supplemental Identifiers

RxCUI
2677793 2677798
UNII
Y7543E5K9T

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ryzumvi (source: ndc)
Generic Name phentolamine mesylate (source: ndc)
Application Number NDA217064 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (83368-075-30) / 5 VIAL, SINGLE-USE in 1 POUCH / .31 mL in 1 VIAL, SINGLE-USE
  • 1 POUCH in 1 CARTON (83368-075-31) / 5 VIAL, SINGLE-USE in 1 POUCH / .31 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

83368-075-30 6 POUCH in 1 CARTON (83368-075-30) / 5 VIAL, SINGLE-USE in 1 POUCH / .31 mL in 1 VIAL, SINGLE-USE 83368-075-31 1 POUCH in 1 CARTON (83368-075-31) / 5 VIAL, SINGLE-USE in 1 POUCH / .31 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

phentolamine mesylate (10 mg/mL)

Linked Drug Pages (1)

Ryzumvi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "7f954669-af25-4d50-8430-36dcc77fd78f", "openfda": {"unii": ["Y7543E5K9T"], "rxcui": ["2677793", "2677798"], "spl_set_id": ["96bb1e53-c2cc-4e60-a21a-db0269c371bf"], "manufacturer_name": ["Oyster Point Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (83368-075-30)  / 5 VIAL, SINGLE-USE in 1 POUCH / .31 mL in 1 VIAL, SINGLE-USE", "package_ndc": "83368-075-30", "marketing_start_date": "20240325"}, {"sample": true, "description": "1 POUCH in 1 CARTON (83368-075-31)  / 5 VIAL, SINGLE-USE in 1 POUCH / .31 mL in 1 VIAL, SINGLE-USE", "package_ndc": "83368-075-31", "marketing_start_date": "20240925"}], "brand_name": "Ryzumvi", "product_id": "83368-075_7f954669-af25-4d50-8430-36dcc77fd78f", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "83368-075", "generic_name": "phentolamine mesylate", "labeler_name": "Oyster Point Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ryzumvi", "active_ingredients": [{"name": "PHENTOLAMINE MESYLATE", "strength": "10 mg/mL"}], "application_number": "NDA217064", "marketing_category": "NDA", "marketing_start_date": "20240325", "listing_expiration_date": "20261231"}