🇺🇸
United States · US · US:44567-705_6bfcc077-8c32-4c7e-abaa-f17eb2084231
Imipenem and Cilastatin
Orange BookUNIISPLATC J01DH
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWG Critical Care, LLC
CountryUS (United States)
ATC codeJ01DH
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11445677051010 VIAL in 1 CARTON (44567-705-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
Annotations
UNII (FDA Substance ID)
5428WXZ74M
CILASTATIN SODIUM
RxCUI 82128
Orange Book
A207594
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5428WXZ74M",
"rxcui": "82128",
"inchikey": "QXPBTTUOVWMPJN-QBNHLFMHSA-M",
"display_name": "CILASTATIN SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"46f54df9-5afe-430c-aa19-0d84c2044b0b": {
"match": "brand_token",
"title": "IMIPENEM AND CILASTATIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]",
"spl_version": "8",
"published_date": "2025-01-20"
}
},
"productid": "44567-705_6bfcc077-8c32-4c7e-abaa-f17eb2084231",
"productndc": "44567-705",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "207594",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL;500MG/VIAL",
"product_no": "001",
"approval_date": "Dec 12, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CILASTATIN SODIUM; IMIPENEM ANHYDROUS",
"proprietary_name": "Imipenem and Cilastatin",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA207594",
"marketing_category": "ANDA",
"nonproprietary_name": "Imipenem and Cilastatin",
"start_marketing_date": "20210309",
"active_numerator_strength": "500; 500"
}Related drugs
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- 🇺🇸Imipenem and CilastatinFresenius Kabi USA, LLC
- 🇺🇸Imipenem and CilastatinFresenius Kabi USA, LLC
- 🇺🇸Imipenem and CilastatinFresenius Kabi USA, LLC
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