Current NDC auxiliary source row compounder:649

This page is keyed by dataset, FDA.report source record ID, and physical source row number. Empty values are shown rather than omitted.

Complete normalized row#

Record Source: ndc_compounder_zip
Product Ndc Raw: 81375-103
Product Ndc: 81375-103
Product Ndc Digits: 81375103
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Mitomycin Bladder Irrigation with Attached Closed System Device
Proprietary Name Suffix: [empty]
Nonproprietary Name: Mitomycin 1mg/mL 40mL Syringe
Dosage Form Name: IRRIGANT
Route Name: INTRAVESICAL
Marketing Category Name: OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Name: PQ Pharmacy LLC
Establishment Name: PQ Pharmacy LLC
Establishment Fei: [empty]
Substance Name: MITOMYCIN
Active Ingredients Info: 1 mg/1 mL
History Active Ingredients Raw: MITOMYCIN
History Active Ingredients Info Raw: 1 mg/1 mL
History Dosage Raw: IRRIGANT
Dea Schedule: [empty]
Package Ndc Raw: 81375-103-40
Package Ndc: 81375-103-40
Package Ndc Digits: 8137510340
Package Ndc11: 81375010340
Package Description: 40 mL in 1 SYRINGE (81375-103-40)
Reporting Period Raw: 2025-1
Reporting Period: 2025-1
Normalization Status: valid
Source Url: https://www.accessdata.fda.gov/cder/compounders_ndc_directory.zip
Source Archive: compounders_ndc_directory.zip
Source File: compounders_ndc_directory.txt
Source Date: 2026-09-18
Source Last Modified: Fri, 18 Sep 2026 15:17:23 GMT
Source Archive Sha256: 222f6800f79cb1a0fa79431b7226bd6b34899999dbf086af51004a96774ada98
Source Member Sha256: f8d9743e5616579a34d614887e86a53913efa0a63d3138d59d2f87cbb4d0cc17
Source Record Id: compounder:649
Source Row Number: 649
Source Row Hash: 94d79992701725693cdf5b653ddc3303c5541290486a89d6c02dc65eb78f20a2
Import Run Id: 20261018T022251Z
Loaded At: 2026-10-18 02:29:51

Exact raw FDA source fields#

{
    "ROUTENAME": "INTRAVESICAL",
    "PRODUCTNDC": "81375-103",
    "DEASCHEDULE": "",
    "LABELERNAME": "PQ Pharmacy LLC",
    "SUBSTANCENAME": "MITOMYCIN",
    "DOSAGEFORMNAME": "IRRIGANT",
    "NDCPACKAGECODE": "81375-103-40",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Mitomycin Bladder Irrigation with Attached Closed System Device",
    "REPORTINGPERIOD": "2025-1",
    "NONPROPRIETARYNAME": "Mitomycin 1mg/mL 40mL Syringe",
    "PACKAGEDESCRIPTION": "40 mL in 1 SYRINGE (81375-103-40) ",
    "ACTIVEINGREDIENTSINFO": "1 mg/1 mL",
    "MARKETINGCATEGORYNAME": "OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)",
    "PROPRIETARYNAMESUFFIX": ""
}

Normalization notes#

[]

Current status projection#

Dataset: compounder
Record Source: ndc_compounder_zip
Source Record Id: compounder:649
Source Row Number: 649
Status Scope: package
Lookup Ndc: 81375-103-40
Lookup Ndc Digits: 8137510340
Product Ndc: 81375-103
Product Ndc Digits: 81375103
Package Ndc: 81375-103-40
Package Ndc Digits: 8137510340
Package Ndc11: 81375010340
Product Id: [empty]
Status Code: COMPOUNDER
Status Label: Outsourcing facility compounded drug report
Reporting Period Raw: 2025-1
Reporting Period: 2025-1
Source Table: fda_ndc_aux_compounder
Source File: compounders_ndc_directory.txt
Source Date: 2026-09-18
Source Row Hash: 94d79992701725693cdf5b653ddc3303c5541290486a89d6c02dc65eb78f20a2
Import Run Id: 20261018T022251Z
Loaded At: 2026-10-18 02:29:51