Current NDC auxiliary source row compounder:560

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: 81375-001
Product Ndc: 81375-001
Product Ndc Digits: 81375001
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Cyclosporine Ophthalmic Emulsion
Proprietary Name Suffix: [empty]
Nonproprietary Name: Cyclosporine 0.1%
Dosage Form Name: SOLUTION/ DROPS
Route Name: OPHTHALMIC
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: 9-(N-METHYL-L-ISOLEUCINE)-CYCLOSPORIN A
Active Ingredients Info: 1 mg/1 mL
History Active Ingredients Raw: 9-(N-METHYL-L-ISOLEUCINE)-CYCLOSPORIN A
History Active Ingredients Info Raw: 1 mg/1 mL
History Dosage Raw: SOLUTION/ DROPS
Dea Schedule: [empty]
Package Ndc Raw: 81375-001-05
Package Ndc: 81375-001-05
Package Ndc Digits: 8137500105
Package Ndc11: 81375000105
Package Description: 5.6 mL in 1 BOTTLE, DROPPER (81375-001-05)
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:560
Source Row Number: 560
Source Row Hash: a86f6b0bf0fdf14694af3d1518b90090870f6cfbce4987cfffbb1d241dc2dfbd
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20

Exact raw FDA source fields#

{
    "ROUTENAME": "OPHTHALMIC",
    "PRODUCTNDC": "81375-001",
    "DEASCHEDULE": "",
    "LABELERNAME": "PQ Pharmacy LLC",
    "SUBSTANCENAME": "9-(N-METHYL-L-ISOLEUCINE)-CYCLOSPORIN A",
    "DOSAGEFORMNAME": "SOLUTION/ DROPS",
    "NDCPACKAGECODE": "81375-001-05",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Cyclosporine Ophthalmic Emulsion",
    "REPORTINGPERIOD": "2025-1",
    "NONPROPRIETARYNAME": "Cyclosporine 0.1%",
    "PACKAGEDESCRIPTION": "5.6 mL in 1 BOTTLE, DROPPER (81375-001-05) ",
    "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:560
Source Row Number: 560
Status Scope: package
Lookup Ndc: 81375-001-05
Lookup Ndc Digits: 8137500105
Product Ndc: 81375-001
Product Ndc Digits: 81375001
Package Ndc: 81375-001-05
Package Ndc Digits: 8137500105
Package Ndc11: 81375000105
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: a86f6b0bf0fdf14694af3d1518b90090870f6cfbce4987cfffbb1d241dc2dfbd
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20