🇺🇸
United States · US · US:42023-116_d7f1fa93-f653-4c83-a782-97ab5330dc39
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
- ndc11420231160225 VIAL in 1 CARTON (42023-116-02) / 10 mL in 1 VIAL
- ndc11420231162525 VIAL in 1 TRAY (42023-116-25) / 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_d7f1fa93-f653-4c83-a782-97ab5330dc39",
"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": "20080201",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code H01BB02.
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- IEOfost 10 IU/ml concentrate for solution for infusion or solution for intramuscular injectionAS Grindeks
- IEOfost 5 IU/ml concentrate for solution for infusion or solution for intramuscular injectionAS Grindeks
- 🇪🇸OXITOCINA KABI 10 UI/ML SOLUCION INYECTABLE Y PARA PERFUSION EFGFresenius Kabi España, S.A.U.
- 🇪🇸OXITOCINA KABI 5 UI/ML SOLUCION INYECTABLE Y PARA PERFUSION EFGFresenius Kabi España, S.A.U.
- 🇺🇸OxytocinCardinal Health 107, LLC
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