🇺🇸
United States · US · US:43598-182_933d3739-a253-94c4-c37e-7872f700ba79
phenylephrine hydrochloride injection, solution
Orange BookUNIISPLATC R01AA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC codeR01AA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1143598182055 BAG in 1 CARTON (43598-182-05) / 250 mL in 1 BAG (43598-182-50)
Annotations
UNII (FDA Substance ID)
1WS297W6MV
PHENYLEPHRINE
RxCUI 8163
Orange Book
N216830
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1WS297W6MV",
"rxcui": "8163",
"inchikey": "SONNWYBIRXJNDC-VIFPVBQESA-N",
"display_name": "PHENYLEPHRINE",
"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": "43598-182_933d3739-a253-94c4-c37e-7872f700ba79",
"productndc": "43598-182",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "216830",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "20MG/250ML (0.08MG/ML)",
"product_no": "001",
"approval_date": "May 30, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENYLEPHRINE",
"proprietary_name": "phenylephrine hydrochloride injection, solution",
"active_ingred_unit": "ug/mL",
"application_number": "NDA216830",
"marketing_category": "NDA",
"nonproprietary_name": "phenylephrine hydrochloride injection, solution",
"start_marketing_date": "20250701",
"active_numerator_strength": "80"
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