Penicillin G Potassium

In shortageOrange BookUNIISPLATC J01CE01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAvenacy Inc.

CountryUS (United States)

ATC codeJ01CE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8363410351
1 VIAL in 1 CARTON (83634-103-51) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Annotations

UNII (FDA Substance ID)

VL775ZTH4C

PENICILLIN G POTASSIUM

RxCUI 203133

Orange Book

A065448

APAP

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": "83634-103_727994cd-436d-4347-a023-5a861abd3264",
  "productndc": "83634-103",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "065448",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5,000,000 UNITS/VIAL",
        "product_no": "001",
        "approval_date": "Aug 18, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20,000,000 UNITS/VIAL",
        "product_no": "002",
        "approval_date": "Aug 18, 2009"
      }
    ],
    "appl_type": "A"
  },
  "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]/1",
  "application_number": "ANDA065448",
  "marketing_category": "ANDA",
  "nonproprietary_name": "penicillin g potassium",
  "start_marketing_date": "20250201",
  "active_numerator_strength": "20000000"
}

Related drugs

Other records sharing ATC code J01CE01.

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