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United States · US · US:63323-012_3649e8ed-929c-4600-9d63-3d77fbe3a0f5

Oxytocin

Orange BookUNIISPLATC H01BB02

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

Identification

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

Packs · 3

  • ndc11
    6332301210
    25 VIAL, MULTI-DOSE in 1 TRAY (63323-012-10) / 10 mL in 1 VIAL, MULTI-DOSE (63323-012-06)
  • ndc11
    6332301211
    25 VIAL in 1 TRAY (63323-012-11) / 1 mL in 1 VIAL (63323-012-03)
  • ndc11
    6332301230
    10 VIAL, MULTI-DOSE in 1 TRAY (63323-012-30) / 30 mL in 1 VIAL, MULTI-DOSE (63323-012-02)

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": "63323-012_3649e8ed-929c-4600-9d63-3d77fbe3a0f5",
  "productndc": "63323-012",
  "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": "20000810",
  "active_numerator_strength": "10"
}

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