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United States · US · US:0143-9564_264ee71e-7e33-4693-b993-8ee0cc2f8d48

Phentolamine Mesylate

Orange BookUNIISPLATC C04AB01

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

Identification

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

Packs · 2

  • ndc11
    0143956401
    1 VIAL in 1 BOX (0143-9564-01) / 1 mL in 1 VIAL
  • ndc11
    0143956410
    10 VIAL in 1 BOX (0143-9564-10) / 1 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
Y7543E5K9T
PHENTOLAMINE MESYLATE
RxCUI 227240
Orange Book
A040235
AP
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": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "e146c7ee-d2fa-433c-8768-0945e4ff0990": {
      "match": "brand_token",
      "title": "PHENTOLAMINE MESYLATE INJECTION [PRECISION DOSE INC.]",
      "spl_version": "12",
      "published_date": "2024-08-23"
    }
  },
  "productid": "0143-9564_264ee71e-7e33-4693-b993-8ee0cc2f8d48",
  "productndc": "0143-9564",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "040235",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "5MG/VIAL",
        "product_no": "001",
        "approval_date": "Mar 11, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHENTOLAMINE MESYLATE",
  "proprietary_name": "Phentolamine Mesylate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA040235",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phentolamine Mesylate",
  "start_marketing_date": "19980515",
  "active_numerator_strength": "5"
}

Related drugs

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