🇺🇸
United States · US · US:0641-6118_43dd9102-1a8e-47c9-a65c-fc50ab4bbf5a
Ampicillin and Sulbactam
In shortageOrange BookUNIISPLATC J01CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeJ01CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110641611801100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01)
Annotations
UNII (FDA Substance ID)
JFN36L5S8K
AMPICILLIN SODIUM
RxCUI 81953
Orange Book
A065403
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ampicillin Sodium Injection
Raw payload (JSON)
{
"unii": {
"unii": "JFN36L5S8K",
"rxcui": "81953",
"inchikey": "KLOHDWPABZXLGI-YWUHCJSESA-M",
"display_name": "AMPICILLIN SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"72a37674-8cb2-4b40-aac8-d345ffcf22f2": {
"match": "brand_token",
"title": "AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]",
"spl_version": "7",
"published_date": "2026-05-14"
}
},
"productid": "0641-6118_43dd9102-1a8e-47c9-a65c-fc50ab4bbf5a",
"productndc": "0641-6118",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "065403",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL",
"product_no": "001",
"approval_date": "Dec 23, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
"shortage_reason": "Ampicillin Sodium Injection",
"shortage_status": "current",
"proprietary_name": "Ampicillin and Sulbactam",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "ANDA065403",
"marketing_category": "ANDA",
"nonproprietary_name": "Ampicillin and Sulbactam",
"start_marketing_date": "20091203",
"active_numerator_strength": "100; 50"
}Related drugs
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