🇺🇸
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
- ndc11633230121025 VIAL, MULTI-DOSE in 1 TRAY (63323-012-10) / 10 mL in 1 VIAL, MULTI-DOSE (63323-012-06)
- ndc11633230121125 VIAL in 1 TRAY (63323-012-11) / 1 mL in 1 VIAL (63323-012-03)
- ndc11633230123010 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"
}Related drugs
Other records sharing ATC code H01BB02.
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- CZOFOSTAS GRINDEKS, Riga
- CZOFOSTAS GRINDEKS, Riga
- 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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