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United States · US · US:25021-197_0e1963ba-9650-44ba-9ba0-1817b0e73512
Ampicillin Sodium
In shortageOrange BookUNIISPLATC J01CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeJ01CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1125021197991 BOTTLE in 1 CARTON (25021-197-99) / 100 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
JFN36L5S8K
AMPICILLIN SODIUM
RxCUI 81953
Orange Book
A201404
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": "25021-197_0e1963ba-9650-44ba-9ba0-1817b0e73512",
"productndc": "25021-197",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "201404",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 10GM BASE/VIAL",
"product_no": "001",
"approval_date": "Dec 20, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMPICILLIN SODIUM",
"shortage_reason": "Ampicillin Sodium Injection",
"shortage_status": "current",
"proprietary_name": "Ampicillin Sodium",
"active_ingred_unit": "g/100mL",
"application_number": "ANDA201404",
"marketing_category": "ANDA",
"nonproprietary_name": "Ampicillin Sodium",
"start_marketing_date": "20250115",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code J01CA01.
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