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United States · US · US:0362-0101_f0465990-acce-46dc-9290-344dab1e4f2f

Oraverse

Orange BookUNIIATC C04AB01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSeptodont, Inc.
CountryUS (United States)
ATC codeC04AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0362010110
    10 CARTRIDGE in 1 CARTON (0362-0101-10) / 1.7 mL in 1 CARTRIDGE

Annotations

UNII (FDA Substance ID)
Y7543E5K9T
PHENTOLAMINE MESYLATE
RxCUI 227240
Orange Book
N022159
Raw payload (JSON)
{
  "unii": {
    "unii": "Y7543E5K9T",
    "rxcui": "227240",
    "inchikey": "OGIYDFVHFQEFKQ-UHFFFAOYSA-N",
    "display_name": "PHENTOLAMINE MESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBMUCOSAL",
  "productid": "0362-0101_f0465990-acce-46dc-9290-344dab1e4f2f",
  "productndc": "0362-0101",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "022159",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.4MG/1.7ML",
        "product_no": "001",
        "approval_date": "May 9, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHENTOLAMINE MESYLATE",
  "proprietary_name": "Oraverse",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022159",
  "marketing_category": "NDA",
  "nonproprietary_name": "Phentolamine Mesylate",
  "start_marketing_date": "20110601",
  "active_numerator_strength": ".235"
}

Related drugs

Other records sharing ATC code C04AB01.

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