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United States · US · US:0143-9139_e32063de-96fe-4fb4-9176-5a9d6dc4a722
Cefazolin
Orange BookUNIISPLATC J01DB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeJ01DB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11014391392525 VIAL in 1 CARTON (0143-9139-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
Annotations
UNII (FDA Substance ID)
P380M0454Z
CEFAZOLIN SODIUM
RxCUI 203171
Orange Book
N216109
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": "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": "0143-9139_e32063de-96fe-4fb4-9176-5a9d6dc4a722",
"productndc": "0143-9139",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "216109",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 2GM BASE/VIAL",
"product_no": "001",
"approval_date": "Oct 7, 2022"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 3GM BASE/VIAL",
"product_no": "002",
"approval_date": "Oct 7, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEFAZOLIN SODIUM",
"proprietary_name": "Cefazolin",
"active_ingred_unit": "g/1",
"application_number": "NDA216109",
"marketing_category": "NDA",
"nonproprietary_name": "Cefazolin",
"start_marketing_date": "20230301",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code J01DB.
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