PRE-PEN

UNIISPL

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

Identification

ManufacturerALK-ABELLO, INC.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4947100105
5 AMPULE in 1 CARTON (49471-001-05) / .25 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)

76479814OY

BENZYLPENICILLOYL POLYLYSINE

RxCUI 19079

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "76479814OY",
    "rxcui": "19079",
    "inchikey": null,
    "display_name": "BENZYLPENICILLOYL POLYLYSINE",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRADERMAL; SUBCUTANEOUS",
  "spl_meta": {
    "2fbcc40c-f102-4abe-bce5-a93de95874fe": {
      "match": "brand_token",
      "title": "PRE-PEN (BENZYLPENICILLOYL POLYLYSINE) INJECTION [ALK-ABELLO, INC.]",
      "spl_version": "5",
      "published_date": "2026-04-02"
    }
  },
  "productid": "49471-001_630c84ab-994f-4686-99bc-deaf6db7cff2",
  "productndc": "49471-001",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZYLPENICILLOYL POLYLYSINE",
  "proprietary_name": "PRE-PEN",
  "active_ingred_unit": "umol/.25mL",
  "application_number": "BLA050114",
  "marketing_category": "BLA",
  "nonproprietary_name": "benzylpenicilloyl polylysine",
  "start_marketing_date": "19740725",
  "active_numerator_strength": "60"
}

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