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United States · US · US:0049-0024_f96b8c10-d100-47bd-9c4a-3bcce67b1758

UNASYN

In shortageOrange BookUNIISPLATC J01CA

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

Identification

ManufacturerRoerig
CountryUS (United States)
ATC codeJ01CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0049002428
    1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0049-0024-28) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Annotations

UNII (FDA Substance ID)
JFN36L5S8K
AMPICILLIN SODIUM
RxCUI 81953
Orange Book
N050608
APAPAP
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": {
    "155c7ec0-5862-404f-b1d0-f278f8a8bbda": {
      "match": "brand_token",
      "title": "UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]",
      "spl_version": "45",
      "published_date": "2025-05-15"
    }
  },
  "productid": "0049-0024_f96b8c10-d100-47bd-9c4a-3bcce67b1758",
  "productndc": "0049-0024",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "050608",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Dec 31, 1986"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Dec 31, 1986"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL",
        "product_no": "003",
        "approval_date": "Dec 31, 1986"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL",
        "product_no": "005",
        "approval_date": "Dec 10, 1993"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
  "shortage_reason": "Ampicillin Sodium Injection",
  "shortage_status": "current",
  "proprietary_name": "UNASYN",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA050608",
  "marketing_category": "NDA",
  "nonproprietary_name": "ampicillin sodium and sulbactam sodium",
  "start_marketing_date": "19911122",
  "active_numerator_strength": "100; 50"
}

Related drugs

Other records sharing ATC code J01CA.

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