PHENYLEPHRINE HYDROCHLORIDE

Orange BookUNIISPLATC R01AA04

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeR01AA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3172234431
10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (31722-344-31) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE

Annotations

UNII (FDA Substance ID)

04JA59TNSJ

PHENYLEPHRINE HYDROCHLORIDE

RxCUI 8164

Orange Book

A218110

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": "31722-344_23a5b85f-4414-6b2b-e063-6394a90aee77",
  "productndc": "31722-344",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "218110",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP1",
        "strength": "10MG/ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "May 10, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP1",
        "strength": "50MG/5ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "May 10, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP1",
        "strength": "100MG/10ML (10MG/ML)",
        "product_no": "003",
        "approval_date": "May 10, 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": "ANDA218110",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PHENYLEPHRINE HYDROCHLORIDE",
  "start_marketing_date": "20240510",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R01AA04.

Access this data programmatically

Query PHENYLEPHRINE HYDROCHLORIDE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs