Penicillin V Potassium

In shortageOrange BookUNIISPLATC J01CE02

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeJ01CE02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6318753300
100 mL in 1 BOTTLE (63187-533-00)
ndc11
6318753320
200 mL in 1 BOTTLE (63187-533-20)

Annotations

UNII (FDA Substance ID)

146T0TU1JB

PENICILLIN V POTASSIUM

RxCUI 203195

Orange Book

A060456

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Penicillin G Benzathine Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "146T0TU1JB",
    "rxcui": "203195",
    "inchikey": "HCTVWSOKIJULET-LQDWTQKMSA-M",
    "display_name": "PENICILLIN V POTASSIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "63187-533_d9fdfb61-581b-4082-ac22-60dc2970ffa2",
  "productndc": "63187-533",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "060456",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 125MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 250MG BASE/5ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PENICILLIN V POTASSIUM",
  "shortage_reason": "Penicillin G Benzathine Injection",
  "shortage_status": "current",
  "proprietary_name": "Penicillin V Potassium",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA060456",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Penicillin V Potassium",
  "start_marketing_date": "19900930",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code J01CE02.

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