Current NDC auxiliary source row compounder:459

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: 83826-9076
Product Ndc: 83826-9076
Product Ndc Digits: 838269076
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Cyclopentolate HCl, Tropicamide, Phenylephrine HCl
Proprietary Name Suffix: [empty]
Nonproprietary Name: Cyclopentolate HCl1%,Tropicamide 1%, Phenylephrine HCl 2.5%
Dosage Form Name: SOLUTION
Route Name: OPHTHALMIC; TOPICAL
Marketing Category Name: OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Name: OSRX, Inc.
Establishment Name: OSRX, Inc.
Establishment Fei: [empty]
Substance Name: PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE; CYCLOPENTOLATE HYDROCHLORIDE
Active Ingredients Info: 25 mg/1 mL; 10 mg/1 mL; 10 mg/1 mL
History Active Ingredients Raw: PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE; CYCLOPENTOLATE HYDROCHLORIDE
History Active Ingredients Info Raw: 25 mg/1 mL; 10 mg/1 mL; 10 mg/1 mL
History Dosage Raw: SOLUTION
Dea Schedule: [empty]
Package Ndc Raw: 83826-9076-5
Package Ndc: 83826-9076-5
Package Ndc Digits: 8382690765
Package Ndc11: 83826907605
Package Description: 5 mL in 1 BOTTLE, DROPPER (83826-9076-5)
Reporting Period Raw: 2026-1
Reporting Period: 2026-1
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:459
Source Row Number: 459
Source Row Hash: c40fe81ca7c326c6a47614aed66238293af1661458357755b82487dd6804f861
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20

Exact raw FDA source fields#

{
    "ROUTENAME": "OPHTHALMIC; TOPICAL",
    "PRODUCTNDC": "83826-9076",
    "DEASCHEDULE": "",
    "LABELERNAME": "OSRX, Inc.",
    "SUBSTANCENAME": "PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE; CYCLOPENTOLATE HYDROCHLORIDE",
    "DOSAGEFORMNAME": "SOLUTION",
    "NDCPACKAGECODE": "83826-9076-5",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Cyclopentolate HCl, Tropicamide, Phenylephrine HCl",
    "REPORTINGPERIOD": "2026-1",
    "NONPROPRIETARYNAME": "Cyclopentolate HCl1%,Tropicamide 1%, Phenylephrine HCl 2.5%",
    "PACKAGEDESCRIPTION": "5 mL in 1 BOTTLE, DROPPER (83826-9076-5) ",
    "ACTIVEINGREDIENTSINFO": "25 mg/1 mL; 10 mg/1 mL; 10 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:459
Source Row Number: 459
Status Scope: package
Lookup Ndc: 83826-9076-5
Lookup Ndc Digits: 8382690765
Product Ndc: 83826-9076
Product Ndc Digits: 838269076
Package Ndc: 83826-9076-5
Package Ndc Digits: 8382690765
Package Ndc11: 83826907605
Product Id: [empty]
Status Code: COMPOUNDER
Status Label: Outsourcing facility compounded drug report
Reporting Period Raw: 2026-1
Reporting Period: 2026-1
Source Table: fda_ndc_aux_compounder
Source File: compounders_ndc_directory.txt
Source Date: 2026-09-18
Source Row Hash: c40fe81ca7c326c6a47614aed66238293af1661458357755b82487dd6804f861
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20