🇺🇸
United States · US · US:63323-322_2bb9b6ad-8e8d-4667-b108-b57a8c16318f
Imipenem and Cilastatin
Orange BookUNIISPLATC J01DH
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeJ01DH
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11633233222525 VIAL, SINGLE-DOSE in 1 CARTON (63323-322-25) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-322-01)
Annotations
UNII (FDA Substance ID)
5428WXZ74M
CILASTATIN SODIUM
RxCUI 82128
Orange Book
A090577
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": "63323-322_2bb9b6ad-8e8d-4667-b108-b57a8c16318f",
"productndc": "63323-322",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "090577",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "EQ 250MG BASE/VIAL;250MG/VIAL",
"product_no": "001",
"approval_date": "Dec 21, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 500MG BASE/VIAL;500MG/VIAL",
"product_no": "002",
"approval_date": "Dec 21, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CILASTATIN SODIUM; IMIPENEM",
"proprietary_name": "Imipenem and Cilastatin",
"active_ingred_unit": "mg/20mL; mg/20mL",
"application_number": "ANDA090577",
"marketing_category": "ANDA",
"nonproprietary_name": "Imipenem and Cilastatin Sodium",
"start_marketing_date": "20120103",
"active_numerator_strength": "500; 500"
}Related drugs
Other records sharing ATC code J01DH.
- GBImipenem 500mg / Cilastatin 500mg powder for solution for infusion vialsFresenius Kabi Ltd
- GBImipenem 500mg / Cilastatin 500mg powder for solution for infusion vialsKent Pharma (UK) Ltd
- GBImipenem 500mg / Cilastatin 500mg powder for solution for infusion vialsA A H Pharmaceuticals Ltd
- GBImipenem 500mg / Cilastatin 500mg powder for solution for infusion vialsPfizer Ltd
- GBImipenem 500mg / Cilastatin 500mg powder for solution for infusion vialsActavis UK Ltd
- 🇺🇸Imipenem and CilastatinWG Critical Care, LLC
- 🇺🇸Imipenem and CilastatinFresenius Kabi USA, LLC
- 🇺🇸Imipenem and CilastatinFresenius Kabi USA, LLC
Access this data programmatically
Query Imipenem and Cilastatin and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.