🇺🇸
United States · US · US:68094-101_4ecf4179-a773-4f75-a48b-a0b2c51facc2
PHENTOLAMINE MESYLATE
Orange BookUNIISPLATC C04AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPrecision Dose Inc.
CountryUS (United States)
ATC codeC04AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168094101201 VIAL in 1 CARTON (68094-101-20) / 1 INJECTION in 1 VIAL
Annotations
UNII (FDA Substance ID)
Y7543E5K9T
PHENTOLAMINE MESYLATE
RxCUI 227240
Orange Book
A207686
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": "68094-101_4ecf4179-a773-4f75-a48b-a0b2c51facc2",
"productndc": "68094-101",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "207686",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "5MG/VIAL",
"product_no": "001",
"approval_date": "Jul 14, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENTOLAMINE MESYLATE",
"proprietary_name": "PHENTOLAMINE MESYLATE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207686",
"marketing_category": "ANDA",
"nonproprietary_name": "PHENTOLAMINE MESYLATE",
"start_marketing_date": "20170715",
"active_numerator_strength": "5"
}Related drugs
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- NLRegitine, 10 mg/ml oplossing voor injectieACE Pharmaceuticals B.V.
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