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United States · US · US:62541-406_36e934b1-3fbb-8f0c-e063-6294a90a968c

PANCREAZE

UNIISPL

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

Identification

ManufacturerVIVUS LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6254140610
    2 BOTTLE, GLASS in 1 CARTON (62541-406-10) / 50 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS (62541-406-50)

Annotations

UNII (FDA Substance ID)
YOJ58O116E
PANCRELIPASE AMYLASE
RxCUI 1427033
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "YOJ58O116E",
    "rxcui": "1427033",
    "inchikey": null,
    "display_name": "PANCRELIPASE AMYLASE",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e8f5d2fe-728d-42af-99a6-83dddc6539c5": {
      "match": "brand_token",
      "title": "PANCREAZE (PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, AND PANCRELIPASE PROTEASE) CAPSULE, DELAYED RELEASE [VIVUS LLC]",
      "spl_version": "17",
      "published_date": "2025-06-09"
    }
  },
  "productid": "62541-406_36e934b1-3fbb-8f0c-e063-6294a90a968c",
  "productndc": "62541-406",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE",
  "proprietary_name": "PANCREAZE",
  "active_ingred_unit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
  "application_number": "BLA022523",
  "marketing_category": "BLA",
  "nonproprietary_name": "PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE",
  "start_marketing_date": "20210701",
  "active_numerator_strength": "149900; 37000; 97300"
}

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