Package 83368-075-31

Brand: ryzumvi

Generic: phentolamine mesylate
NDC Package Sample

Package Facts

Identity

Package NDC 83368-075-31
Digits Only 8336807531
Product NDC 83368-075
Description

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

Marketing

Marketing Status
Marketed Since 2024-09-25
Brand ryzumvi
Generic phentolamine mesylate
Sample Package Yes

Linked Drug Pages (1)

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"}