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United States · US · US:68788-8242_f750aa5e-5596-4c7f-956c-2eeb130c1ed3

Penicillin V Potassium

In shortageOrange BookUNIISPLATC J01CE02

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ01CE02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6878882422
    28 TABLET, FILM COATED in 1 BOTTLE (68788-8242-2)
  • ndc11
    6878882424
    40 TABLET, FILM COATED in 1 BOTTLE (68788-8242-4)

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": "68788-8242_f750aa5e-5596-4c7f-956c-2eeb130c1ed3",
  "productndc": "68788-8242",
  "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": "20220809",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J01CE02.

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