🇺🇸
United States · US · US:55150-300_a816de08-7a48-43df-a09b-f1f342a230d5
Phenylephrine Hydrochloride
Orange BookUNIISPLATC R01AA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEugia US LLC
CountryUS (United States)
ATC codeR01AA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11551503002525 VIAL, SINGLE-DOSE in 1 CARTON (55150-300-25) / 1 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
04JA59TNSJ
PHENYLEPHRINE HYDROCHLORIDE
RxCUI 8164
Orange Book
A210696
AP2
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "04JA59TNSJ",
"rxcui": "8164",
"inchikey": "OCYSGIYOVXAGKQ-FVGYRXGTSA-N",
"display_name": "PHENYLEPHRINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"d92631a6-bae8-493b-b4df-c563346607a8": {
"match": "brand_token",
"title": "PHENYLEPHRINE HYDROCHLORIDE INJECTION [PAR HEALTH USA, LLC]",
"spl_version": "15",
"published_date": "2026-05-20"
}
},
"productid": "55150-300_a816de08-7a48-43df-a09b-f1f342a230d5",
"productndc": "55150-300",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "210696",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP2",
"strength": "10MG/ML (10MG/ML)",
"product_no": "001",
"approval_date": "Jan 7, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENYLEPHRINE HYDROCHLORIDE",
"proprietary_name": "Phenylephrine Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA210696",
"marketing_category": "ANDA",
"nonproprietary_name": "Phenylephrine Hydrochloride",
"start_marketing_date": "20210107",
"active_numerator_strength": "10"
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