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United States · US · US:23155-620_41aed9d2-a4e5-4503-a88d-17238683779c

phenylephrine hydrochloride

Orange BookUNIISPLATC R01AA04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeR01AA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2315562041
    25 VIAL in 1 CARTON (23155-620-41) / 1 mL in 1 VIAL (23155-620-31)

Annotations

UNII (FDA Substance ID)
04JA59TNSJ
PHENYLEPHRINE HYDROCHLORIDE
RxCUI 8164
Orange Book
A209968
AP2
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": "23155-620_41aed9d2-a4e5-4503-a88d-17238683779c",
  "productndc": "23155-620",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "209968",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP2",
        "strength": "10MG/ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 28, 2023"
      }
    ],
    "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": "ANDA209968",
  "marketing_category": "ANDA",
  "nonproprietary_name": "phenylephrine hydrochloride",
  "start_marketing_date": "20230228",
  "active_numerator_strength": "10"
}

Related drugs

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