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United States · US · US:65219-020_38c6c088-e4ab-4859-b4d9-89e846cf9d5f

Ampicillin

In shortageOrange BookUNIISPLATC J01CA01

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeJ01CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6521902023
    10 VIAL in 1 CARTON (65219-020-23) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-020-03)

Annotations

UNII (FDA Substance ID)
JFN36L5S8K
AMPICILLIN SODIUM
RxCUI 81953
Orange Book
A062797
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": "65219-020_38c6c088-e4ab-4859-b4d9-89e846cf9d5f",
  "productndc": "65219-020",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "062797",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 125MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jul 12, 1993"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jul 12, 1993"
      }
    ],
    "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": "ANDA062797",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ampicillin sodium",
  "start_marketing_date": "20191031",
  "active_numerator_strength": "2"
}

Related drugs

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