Back to search
🇺🇸

United States · US · US:71288-031_f8b66438-eeee-4177-9a49-8fb725dc6672

Ampicillin and Sulbactam

In shortageOrange BookUNIISPLATC J01CA

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

Identification

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

Packs · 1

  • ndc11
    7128803121
    10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20)

Annotations

UNII (FDA Substance ID)
JFN36L5S8K
AMPICILLIN SODIUM
RxCUI 81953
Orange Book
A065222
APAP
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": "71288-031_f8b66438-eeee-4177-9a49-8fb725dc6672",
  "productndc": "71288-031",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "065222",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Nov 29, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL",
        "product_no": "002",
        "approval_date": "Nov 29, 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/1; g/1",
  "application_number": "ANDA065222",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ampicillin sodium and Sulbactam sodium",
  "start_marketing_date": "20051129",
  "active_numerator_strength": "1; .5"
}

Related drugs

Other records sharing ATC code J01CA.

Access this data programmatically

Query Ampicillin and Sulbactam and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.