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United States · US · US:0781-3413_a4c2a8ec-b73a-43e3-ac67-4c6f0d0bef37

Ampicillin

In shortageOrange BookUNIISPLATC J01CA01

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

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeJ01CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0781341392
    10 VIAL, GLASS in 1 PACKAGE (0781-3413-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (0781-3413-15)

Annotations

UNII (FDA Substance ID)
JFN36L5S8K
AMPICILLIN SODIUM
RxCUI 81953
Orange Book
A062738
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": "0781-3413_a4c2a8ec-b73a-43e3-ac67-4c6f0d0bef37",
  "productndc": "0781-3413",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "062738",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Feb 19, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Feb 19, 1987"
      }
    ],
    "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",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA062738",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ampicillin Sodium",
  "start_marketing_date": "19870219",
  "active_numerator_strength": "2"
}

Related drugs

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