Penicillin V Potassium

In shortageOrange BookUNIISPLATC J01CE02

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeJ01CE02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4306368040
40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-680-40)

Annotations

UNII (FDA Substance ID)

146T0TU1JB

PENICILLIN V POTASSIUM

RxCUI 203195

Orange Book

A065435

ABAB

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": "43063-680_413a20e5-ef07-95cc-e063-6294a90a1071",
  "productndc": "43063-680",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "065435",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Apr 29, 2008"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Apr 29, 2008"
      }
    ],
    "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/1",
  "application_number": "ANDA065435",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Penicillin V Potassium",
  "start_marketing_date": "20080429",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J01CE02.

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