Oxytocin

Orange BookUNIISPLATC H01BB02

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeH01BB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6521902101
25 VIAL, SINGLE-DOSE in 1 TRAY (65219-021-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-021-00)

Annotations

UNII (FDA Substance ID)

1JQS135EYN

OXYTOCIN

RxCUI 7824

Orange Book

N018248

APAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "1JQS135EYN",
    "rxcui": "7824",
    "inchikey": null,
    "display_name": "OXYTOCIN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "c7fd585a-99b7-4309-b003-a6cbef05372c": {
      "match": "brand_token",
      "title": "OXYTOCIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]",
      "spl_version": "7",
      "published_date": "2026-02-13"
    }
  },
  "productid": "65219-021_9ac3d1b0-5944-4a20-87b1-423a712f429a",
  "productndc": "65219-021",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "018248",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10USP UNITS/ML (10USP UNITS/ML)",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "100USP UNITS/10ML (10USP UNITS/ML)",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "300USP UNITS/30ML (10USP UNITS/ML)",
        "product_no": "003",
        "approval_date": "Jul 27, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXYTOCIN",
  "proprietary_name": "Oxytocin",
  "active_ingred_unit": "[USP'U]/mL",
  "application_number": "NDA018248",
  "marketing_category": "NDA",
  "nonproprietary_name": "OXYTOCIN",
  "start_marketing_date": "20240506",
  "active_numerator_strength": "10"
}

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