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United States · US · US:44567-212_1d4d49a9-c975-4a1f-beca-9694ce03a532

Ampicillin and Sulbactam

In shortageOrange BookUNIISPLATC J01CA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerWG Critical Care, LLC
CountryUS (United States)
ATC codeJ01CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4456721201
    1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
JFN36L5S8K
AMPICILLIN SODIUM
RxCUI 81953
Orange Book
A065188
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": "44567-212_1d4d49a9-c975-4a1f-beca-9694ce03a532",
  "productndc": "44567-212",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "065188",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Nov 25, 2005"
      }
    ],
    "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": "g/100mL; g/100mL",
  "application_number": "ANDA065188",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ampicillin and Sulbactam",
  "start_marketing_date": "20051125",
  "active_numerator_strength": "10; 5"
}

Related drugs

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