Biorphen

Orange BookUNIISPLATC R01AA04

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

Identification

ManufacturerDr. Reddy's Laboratories Inc.

CountryUS (United States)

ATC codeR01AA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4359817215
10 AMPULE in 1 CARTON (43598-172-15) / 5 mL in 1 AMPULE (43598-172-05)
ndc11
4359817225
5 mL in 1 VIAL (43598-172-25)

Annotations

UNII (FDA Substance ID)

04JA59TNSJ

PHENYLEPHRINE HYDROCHLORIDE

RxCUI 8164

Orange Book

N212909

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": {
    "2f715e4e-b269-b935-d2c9-003cb29770be": {
      "match": "brand_token",
      "title": "BIORPHEN (PHENYLEPHRINE HYDROCHLORIDE) INJECTION, SOLUTION [DR. REDDY'S LABORATORIES INC.]",
      "spl_version": "5",
      "published_date": "2026-04-23"
    }
  },
  "productid": "43598-172_884b0378-92e0-f3ed-176b-ff409f29747f",
  "productndc": "43598-172",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "212909",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.5MG/5ML (0.1MG/ML)",
        "product_no": "001",
        "approval_date": "Oct 21, 2019"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG/ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Mar 11, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Biorphen",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA212909",
  "marketing_category": "NDA",
  "nonproprietary_name": "Phenylephrine hydrochloride",
  "start_marketing_date": "20221125",
  "active_numerator_strength": ".1"
}

Related drugs

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