IMMPHENTIV

Orange BookUNIIATC R01AA04

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeR01AA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0641624510
10 VIAL in 1 CARTON (0641-6245-10) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

04JA59TNSJ

PHENYLEPHRINE HYDROCHLORIDE

RxCUI 8164

Orange Book

N203826

AP2AP2AP2

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",
  "productid": "0641-6245_f73e455e-cbfa-48af-b4ce-505de8e8f761",
  "productndc": "0641-6245",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "203826",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP2",
        "strength": "10MG/ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Dec 20, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP2",
        "strength": "50MG/5ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Jun 19, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP2",
        "strength": "100MG/10ML (10MG/ML)",
        "product_no": "003",
        "approval_date": "Jun 19, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.5MG/5ML (0.1MG/ML)",
        "product_no": "004",
        "approval_date": "Mar 9, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1MG/10ML (0.1MG/ML)",
        "product_no": "005",
        "approval_date": "Mar 9, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "IMMPHENTIV",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA203826",
  "marketing_category": "NDA",
  "nonproprietary_name": "Phenylephrine Hydrochloride",
  "start_marketing_date": "20230309",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code R01AA04.

Access this data programmatically

Query IMMPHENTIV 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