R-Gene

Orange BookUNIISPLATC B05XB01

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

Identification

ManufacturerPharmacia & Upjohn Company LLC

CountryUS (United States)

ATC codeB05XB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0009043601
1 CONTAINER in 1 CARTON (0009-0436-01) / 300 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)

F7LTH1E20Y

ARGININE HYDROCHLORIDE

RxCUI 89918

Orange Book

N016931

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "F7LTH1E20Y",
    "rxcui": "89918",
    "inchikey": "KWTQSFXGGICVPE-WCCKRBBISA-N",
    "display_name": "ARGININE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "6accf33f-9841-4327-8923-93c42020ef12": {
      "match": "brand_token",
      "title": "R-GENE (ARGININE HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]",
      "spl_version": "18",
      "published_date": "2024-04-03"
    }
  },
  "productid": "0009-0436_92dc2b43-3599-4859-b08b-29c024171f08",
  "productndc": "0009-0436",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "016931",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10GM/100ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARGININE HYDROCHLORIDE",
  "proprietary_name": "R-Gene",
  "active_ingred_unit": "g/100mL",
  "application_number": "NDA016931",
  "marketing_category": "NDA",
  "nonproprietary_name": "Arginine Hydrochloride",
  "start_marketing_date": "19760615",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code B05XB01.

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