🇺🇸
United States · US · US:23155-620_41aed9d2-a4e5-4503-a88d-17238683779c
phenylephrine hydrochloride
Orange BookUNIISPLATC R01AA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeR01AA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11231556204125 VIAL in 1 CARTON (23155-620-41) / 1 mL in 1 VIAL (23155-620-31)
Annotations
UNII (FDA Substance ID)
04JA59TNSJ
PHENYLEPHRINE HYDROCHLORIDE
RxCUI 8164
Orange Book
A209968
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": "23155-620_41aed9d2-a4e5-4503-a88d-17238683779c",
"productndc": "23155-620",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "209968",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP2",
"strength": "10MG/ML (10MG/ML)",
"product_no": "001",
"approval_date": "Feb 28, 2023"
}
],
"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": "ANDA209968",
"marketing_category": "ANDA",
"nonproprietary_name": "phenylephrine hydrochloride",
"start_marketing_date": "20230228",
"active_numerator_strength": "10"
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