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United States · US · US:63323-237_321ffc80-ee94-4a86-8c33-e966438d9fbb
CEFAZOLIN
Orange BookUNIISPLATC J01DB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeJ01DB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11633232371025 VIAL in 1 CARTON (63323-237-10) / 3 mL in 1 VIAL (63323-237-01)
Annotations
UNII (FDA Substance ID)
P380M0454Z
CEFAZOLIN SODIUM
RxCUI 203171
Orange Book
A065303
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "P380M0454Z",
"rxcui": "203171",
"inchikey": "FLKYBGKDCCEQQM-WYUVZMMLSA-M",
"display_name": "CEFAZOLIN SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"d91a8d13-99a0-4d87-88dc-71cbd37922b4": {
"match": "brand_token",
"title": "CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]",
"spl_version": "17",
"published_date": "2026-05-21"
}
},
"productid": "63323-237_321ffc80-ee94-4a86-8c33-e966438d9fbb",
"productndc": "63323-237",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "065303",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL",
"product_no": "001",
"approval_date": "Oct 22, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 1GM BASE/VIAL",
"product_no": "002",
"approval_date": "Oct 22, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEFAZOLIN SODIUM",
"proprietary_name": "CEFAZOLIN",
"active_ingred_unit": "g/3mL",
"application_number": "ANDA065303",
"marketing_category": "ANDA",
"nonproprietary_name": "CEFAZOLIN SODIUM",
"start_marketing_date": "20110715",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code J01DB.
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