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United States · US · US:0338-1301_7e2eb55e-e6d6-40a0-9274-274fff3d9262
Cefepime
In shortageOrange BookUNIISPLATC J01DE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBaxter Healthcare Company
CountryUS (United States)
ATC codeJ01DE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11033813014124 BAG in 1 BOX (0338-1301-41) / 50 mL in 1 BAG
- ndc11033813014812 BAG in 1 BOX (0338-1301-48) / 100 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
I8X1O0607P
CEFEPIME HYDROCHLORIDE
RxCUI 236058
Orange Book
N050817
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Cefepime Hydrochloride Injection
Raw payload (JSON)
{
"unii": {
"unii": "I8X1O0607P",
"rxcui": "236058",
"inchikey": "LRAJHPGSGBRUJN-OMIVUECESA-N",
"display_name": "CEFEPIME HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"c654ef2e-1067-4026-8931-6a0dc2a17ad1": {
"match": "brand_token",
"title": "CEFEPIME INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]",
"spl_version": "7",
"published_date": "2026-04-23"
}
},
"productid": "0338-1301_7e2eb55e-e6d6-40a0-9274-274fff3d9262",
"productndc": "0338-1301",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "050817",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 1GM BASE/50ML (EQ 20MG BASE/ML)",
"product_no": "001",
"approval_date": "Aug 5, 2008"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 2GM BASE/100ML (EQ 20MG BASE/ML)",
"product_no": "002",
"approval_date": "Aug 5, 2008"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEFEPIME HYDROCHLORIDE",
"shortage_reason": "Cefepime Hydrochloride Injection",
"shortage_status": "current",
"proprietary_name": "Cefepime",
"active_ingred_unit": "g/50mL",
"application_number": "NDA050817",
"marketing_category": "NDA",
"nonproprietary_name": "cefepime",
"start_marketing_date": "20080805",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code J01DE.
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