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United States · US · US:63323-385_a30c7fcf-f9c0-4b38-bfed-fbd3b1a3e2f8
Cefotetan
Orange BookUNIISPLATC J01DC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeJ01DC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11633233851010 VIAL in 1 CARTON (63323-385-10) / 10 mL in 1 VIAL (63323-385-01)
Annotations
UNII (FDA Substance ID)
0GXP746VXB
CEFOTETAN DISODIUM
RxCUI 203141
Orange Book
A065374
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0GXP746VXB",
"rxcui": "203141",
"inchikey": "ZQQALMSFFARWPK-GLHLDKNHSA-L",
"display_name": "CEFOTETAN DISODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e": {
"match": "brand_token",
"title": "CEFOTETAN (CEFOTETAN DISODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]",
"spl_version": "9",
"published_date": "2025-01-16"
}
},
"productid": "63323-385_a30c7fcf-f9c0-4b38-bfed-fbd3b1a3e2f8",
"productndc": "63323-385",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "065374",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 1GM BASE/VIAL",
"product_no": "001",
"approval_date": "Aug 9, 2007"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 2GM BASE/VIAL",
"product_no": "002",
"approval_date": "Aug 9, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEFOTETAN DISODIUM",
"proprietary_name": "Cefotetan",
"active_ingred_unit": "g/10mL",
"application_number": "ANDA065374",
"marketing_category": "ANDA",
"nonproprietary_name": "CEFOTETAN DISODIUM",
"start_marketing_date": "20091118",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code J01DC05.
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