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United States · US · US:51662-1576_11fff86b-b35b-a576-e063-6394a90a1fa3

PHENYLEPHRINE HYDROCHLORIDE

Orange BookUNIISPLATC R01AA04

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeR01AA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5166215761
    1 mL in 1 VIAL, SINGLE-DOSE (51662-1576-1)
  • ndc11
    5166215763
    25 POUCH in 1 CASE (51662-1576-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1576-2) / 1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
04JA59TNSJ
PHENYLEPHRINE HYDROCHLORIDE
RxCUI 8164
Orange Book
A210665
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": "51662-1576_11fff86b-b35b-a576-e063-6394a90a1fa3",
  "productndc": "51662-1576",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "210665",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP2",
        "strength": "10MG/ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Jan 29, 2019"
      }
    ],
    "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": "ANDA210665",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PHENYLEPHRINE HYDROCHLORIDE",
  "start_marketing_date": "20210630",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R01AA04.

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