Penicillin V Potassium

In shortageOrange BookUNIISPLATC J01CE02

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeJ01CE02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0143983701
100 TABLET, FILM COATED in 1 BOTTLE (0143-9837-01)
ndc11
0143983710
1000 TABLET, FILM COATED in 1 BOTTLE (0143-9837-10)

Annotations

UNII (FDA Substance ID)

146T0TU1JB

PENICILLIN V POTASSIUM

RxCUI 203195

Orange Book

A090549

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": "0143-9837_dd8905b6-bf91-4624-bad7-ad27b01f8113",
  "productndc": "0143-9837",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090549",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Oct 11, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Oct 11, 2013"
      }
    ],
    "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": "ANDA090549",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Penicillin V Potassium",
  "start_marketing_date": "20131011",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code J01CE02.

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