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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

  • ndc11
    4359818205
    5 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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