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United States · US · US:42023-116_d3d010b0-5caf-4f64-9ba6-1d1eeb3dc0b2

Pitocin

Orange BookUNIISPLATC H01BB02

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

Identification

ManufacturerPar Health USA, LLC
CountryUS (United States)
ATC codeH01BB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4202311673
    25 VIAL in 1 CARTON (42023-116-73) / 10 mL in 1 VIAL
  • ndc11
    4202311683
    25 VIAL in 1 CARTON (42023-116-83) / 1 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
1JQS135EYN
OXYTOCIN
RxCUI 7824
Orange Book
N018261
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": "INTRAVENOUS",
  "spl_meta": {
    "6e5a66fc-e507-497c-b5ce-44a8c95898ad": {
      "match": "brand_token",
      "title": "PITOCIN (OXYTOCIN) INJECTION [PAR HEALTH USA, LLC]",
      "spl_version": "15",
      "published_date": "2026-05-21"
    }
  },
  "productid": "42023-116_d3d010b0-5caf-4f64-9ba6-1d1eeb3dc0b2",
  "productndc": "42023-116",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "018261",
    "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": false,
        "rld": true,
        "te_code": "AP",
        "strength": "100USP UNITS/10ML (10USP UNITS/ML)",
        "product_no": "002",
        "approval_date": "Jul 27, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "500USP UNITS/50ML (10USP UNITS/ML)",
        "product_no": "003",
        "approval_date": "Sep 5, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXYTOCIN",
  "proprietary_name": "Pitocin",
  "active_ingred_unit": "[iU]/mL",
  "application_number": "NDA018261",
  "marketing_category": "NDA",
  "nonproprietary_name": "oxytocin",
  "start_marketing_date": "20231222",
  "active_numerator_strength": "10"
}

Related drugs

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