🇺🇸
United States · US · US:63323-751_74cccfa6-0838-4325-8775-53d786e9c72d
Phenylephrine Hydrochloride
Orange BookUNIISPLATC R01AA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeR01AA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11633237510125 VIAL, SINGLE-DOSE in 1 CARTON (63323-751-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-751-00)
Annotations
UNII (FDA Substance ID)
04JA59TNSJ
PHENYLEPHRINE HYDROCHLORIDE
RxCUI 8164
Orange Book
A210665
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": "63323-751_74cccfa6-0838-4325-8775-53d786e9c72d",
"productndc": "63323-751",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "210665",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP2",
"strength": "10MG/ML (10MG/ML)",
"product_no": "001",
"approval_date": "Jan 29, 2019"
}
],
"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": "ANDA210665",
"marketing_category": "ANDA",
"nonproprietary_name": "Phenylephrine Hydrochloride",
"start_marketing_date": "20190525",
"active_numerator_strength": "10"
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