Phenylephrine Hydrochloride

Orange BookUNIISPLATC R01AA04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMethod Pharmaceuticals, LLC

CountryUS (United States)

ATC codeR01AA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5865785211
10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (58657-852-11) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (58657-852-10)

Annotations

UNII (FDA Substance ID)

04JA59TNSJ

PHENYLEPHRINE HYDROCHLORIDE

RxCUI 8164

Orange Book

A218412

AP1AP1AP1

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": "58657-852_4bab5061-fc5e-bd93-e063-6294a90abb9a",
  "productndc": "58657-852",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "218412",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP1",
        "strength": "10MG/ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Mar 14, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP1",
        "strength": "50MG/5ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Mar 14, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP1",
        "strength": "100MG/10ML (10MG/ML)",
        "product_no": "003",
        "approval_date": "Mar 14, 2024"
      }
    ],
    "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": "ANDA218412",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phenylephrine Hydrochloride",
  "start_marketing_date": "20260201",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R01AA04.

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