🇺🇸
United States · US · US:72603-520_e31ea9e0-264f-451a-84f7-578d3445e2dd
Phenylephrine Hydrochloride
Orange BookUNIISPLATC R01AA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthStar RxLLC
CountryUS (United States)
ATC codeR01AA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1172603520011 BOTTLE, DROPPER in 1 CARTON (72603-520-01) / 2 mL in 1 BOTTLE, DROPPER
- ndc1172603520021 BOTTLE, DROPPER in 1 CARTON (72603-520-02) / 15 mL in 1 BOTTLE, DROPPER
Annotations
UNII (FDA Substance ID)
04JA59TNSJ
PHENYLEPHRINE HYDROCHLORIDE
RxCUI 8164
Orange Book
A216859
AT
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": "OPHTHALMIC",
"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": "72603-520_e31ea9e0-264f-451a-84f7-578d3445e2dd",
"productndc": "72603-520",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "216859",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AT",
"strength": "2.5%",
"product_no": "001",
"approval_date": "Sep 29, 2022"
}
],
"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": "ANDA216859",
"marketing_category": "ANDA",
"nonproprietary_name": "Phenylephrine Hydrochloride",
"start_marketing_date": "20241001",
"active_numerator_strength": "25"
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