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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

  • ndc11
    8336807530
    6 POUCH in 1 CARTON (83368-075-30) / 5 VIAL, SINGLE-USE in 1 POUCH / .31 mL in 1 VIAL, SINGLE-USE
  • ndc11
    8336807531
    1 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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