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United States · US · US:72485-418_44e29e92-b036-b2f8-e063-6394a90a7f6a

Ampicillin Sodium and Sulbactam Sodium

In shortageOrange BookUNIISPLATC J01CA

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

Identification

ManufacturerArmas Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ01CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7248541815
    1 BOTTLE in 1 CARTON (72485-418-15) / 15 g in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
JFN36L5S8K
AMPICILLIN SODIUM
RxCUI 81953
Orange Book
A202197
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": "INTRAMUSCULAR; 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": "72485-418_44e29e92-b036-b2f8-e063-6394a90a7f6a",
  "productndc": "72485-418",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "202197",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Apr 7, 2014"
      }
    ],
    "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 Sodium and Sulbactam Sodium",
  "active_ingred_unit": "g/15g; g/15g",
  "application_number": "ANDA202197",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ampicillin sodium, sulbactam sodium",
  "start_marketing_date": "20250501",
  "active_numerator_strength": "10; 5"
}

Related drugs

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