PHENYLEPHRINE HYDROCHLORIDE

Orange BookUNIISPLATC R01AA04

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

Identification

ManufacturerCaplin Steriles Limited

CountryUS (United States)

ATC codeR01AA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6514514801
1 BOTTLE, DROPPER in 1 CARTON (65145-148-01) / 2 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)

04JA59TNSJ

PHENYLEPHRINE HYDROCHLORIDE

RxCUI 8164

Orange Book

A215183

ATAT

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": "65145-148_606202d3-4976-427a-8ced-f8ae0c2a9a4c",
  "productndc": "65145-148",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "215183",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "2.5%",
        "product_no": "001",
        "approval_date": "May 23, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "10%",
        "product_no": "002",
        "approval_date": "May 23, 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": "ANDA215183",
  "marketing_category": "ANDA",
  "nonproprietary_name": "phenylephrine hydrochloride",
  "start_marketing_date": "20250123",
  "active_numerator_strength": "25"
}

Related drugs

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