🇺🇸
United States · US · US:70069-591_5bc23817-cddb-4448-bbf3-969db4cee912
Phenylephrine Hydrochloride
Orange BookUNIISPLATC R01AA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeR01AA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11700695911010 AMPULE in 1 CARTON (70069-591-10) / 5 mL in 1 AMPULE (70069-591-01)
Annotations
UNII (FDA Substance ID)
04JA59TNSJ
PHENYLEPHRINE HYDROCHLORIDE
RxCUI 8164
Orange Book
A215617
AP
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": "70069-591_5bc23817-cddb-4448-bbf3-969db4cee912",
"productndc": "70069-591",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "215617",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.5MG/5ML (0.1MG/ML)",
"product_no": "001",
"approval_date": "Feb 14, 2025"
}
],
"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": "ANDA215617",
"marketing_category": "ANDA",
"nonproprietary_name": "Phenylephrine Hydrochloride",
"start_marketing_date": "20250304",
"active_numerator_strength": ".1"
}Related drugs
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