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United States · US · US:66288-8100_c3258e86-4c07-4656-9767-ca959ecee86d
CEFEPIME
In shortageOrange BookUNIISPLATC J01DE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSAMSON MEDICAL TECHNOLOGIES LLC
CountryUS (United States)
ATC codeJ01DE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1166288810011 BAG in 1 BAG (66288-8100-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG
Annotations
UNII (FDA Substance ID)
I8X1O0607P
CEFEPIME HYDROCHLORIDE
RxCUI 236058
Orange Book
A209408
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": "66288-8100_c3258e86-4c07-4656-9767-ca959ecee86d",
"productndc": "66288-8100",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "209408",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "EQ 100GM BASE",
"product_no": "001",
"approval_date": "Aug 21, 2018"
}
],
"appl_type": "A"
},
"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/1",
"application_number": "ANDA209408",
"marketing_category": "ANDA",
"nonproprietary_name": "CEFEPIME",
"start_marketing_date": "20181001",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code J01DE.
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