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United States · US · US:0404-9835_a5e569a1-da41-44da-a31a-3c9d2c0b61c2
CEFAZOLIN
Orange BookUNIISPLATC J01DB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHenry Schein Inc.
CountryUS (United States)
ATC codeJ01DB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104049835991 VIAL in 1 BAG (0404-9835-99) / 2.2 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
P380M0454Z
CEFAZOLIN SODIUM
RxCUI 203171
Orange Book
A065047
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": "0404-9835_a5e569a1-da41-44da-a31a-3c9d2c0b61c2",
"productndc": "0404-9835",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "065047",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL",
"product_no": "001",
"approval_date": "Sep 18, 2001"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 1GM BASE/VIAL",
"product_no": "002",
"approval_date": "Sep 18, 2001"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEFAZOLIN SODIUM",
"proprietary_name": "CEFAZOLIN",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA065047",
"marketing_category": "ANDA",
"nonproprietary_name": "cefazolin",
"start_marketing_date": "20220109",
"active_numerator_strength": "225"
}Related drugs
Other records sharing ATC code J01DB.
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