🇺🇸
United States · US · US:83368-075_7f954669-af25-4d50-8430-36dcc77fd78f
Ryzumvi
Orange BookUNIISPLATC C04AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOyster Point Pharma, Inc.
CountryUS (United States)
ATC codeC04AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1183368075306 POUCH in 1 CARTON (83368-075-30) / 5 VIAL, SINGLE-USE in 1 POUCH / .31 mL in 1 VIAL, SINGLE-USE
- ndc1183368075311 POUCH in 1 CARTON (83368-075-31) / 5 VIAL, SINGLE-USE in 1 POUCH / .31 mL in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
Y7543E5K9T
PHENTOLAMINE MESYLATE
RxCUI 227240
Orange Book
N217064
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Y7543E5K9T",
"rxcui": "227240",
"inchikey": "OGIYDFVHFQEFKQ-UHFFFAOYSA-N",
"display_name": "PHENTOLAMINE MESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"96bb1e53-c2cc-4e60-a21a-db0269c371bf": {
"match": "brand_token",
"title": "RYZUMVI (PHENTOLAMINE MESYLATE) SOLUTION/ DROPS [OYSTER POINT PHARMA, INC.]",
"spl_version": "4",
"published_date": "2024-11-25"
}
},
"productid": "83368-075_7f954669-af25-4d50-8430-36dcc77fd78f",
"productndc": "83368-075",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "217064",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.75% BASE",
"product_no": "001",
"approval_date": "Sep 25, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENTOLAMINE MESYLATE",
"proprietary_name": "Ryzumvi",
"active_ingred_unit": "mg/mL",
"application_number": "NDA217064",
"marketing_category": "NDA",
"nonproprietary_name": "phentolamine mesylate",
"start_marketing_date": "20240325",
"active_numerator_strength": "10"
}Related drugs
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