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United States · US · US:0338-1023_b7e68f35-c49a-4137-841d-902b1b2b400a

PENICILLIN G POTASSIUM

In shortageOrange BookUNIISPLATC J01CE01

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

Identification

ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeJ01CE01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0338102341
    50 mL in 1 BAG (0338-1023-41)

Annotations

UNII (FDA Substance ID)
VL775ZTH4C
PENICILLIN G POTASSIUM
RxCUI 203133
Orange Book
N050638
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Penicillin G Benzathine Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "VL775ZTH4C",
    "rxcui": "203133",
    "inchikey": "IYNDLOXRXUOGIU-LQDWTQKMSA-M",
    "display_name": "PENICILLIN G POTASSIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f": {
      "match": "brand_token",
      "title": "PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]",
      "spl_version": "11",
      "published_date": "2026-05-22"
    }
  },
  "productid": "0338-1023_b7e68f35-c49a-4137-841d-902b1b2b400a",
  "productndc": "0338-1023",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "050638",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20,000 UNITS/ML",
        "product_no": "001",
        "approval_date": "Jun 25, 1990"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40,000 UNITS/ML",
        "product_no": "002",
        "approval_date": "Jun 25, 1990"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "60,000 UNITS/ML",
        "product_no": "003",
        "approval_date": "Jun 25, 1990"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PENICILLIN G POTASSIUM",
  "shortage_reason": "Penicillin G Benzathine Injection",
  "shortage_status": "current",
  "proprietary_name": "PENICILLIN G POTASSIUM",
  "active_ingred_unit": "[iU]/50mL",
  "application_number": "NDA050638",
  "marketing_category": "NDA",
  "nonproprietary_name": "PENICILLIN G",
  "start_marketing_date": "19900625",
  "active_numerator_strength": "2000000"
}

Related drugs

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