Current NDC auxiliary source row compounder:1749

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: 71449-092
Product Ndc: 71449-092
Product Ndc Digits: 71449092
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Cyclopentolate Hydrochloride, Tropicamide, Phenylephrine Hydrochloride
Proprietary Name Suffix: [empty]
Nonproprietary Name: Cyclopentolate Hydrochloride, Tropicamide, Phenylephrine Hydrochloride
Dosage Form Name: SOLUTION/ DROPS
Route Name: OPHTHALMIC
Marketing Category Name: OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Name: Denver Solutions, LLC dba Leiters Health
Establishment Name: Denver Solutions, LLC dba Leiters Health
Establishment Fei: [empty]
Substance Name: CYCLOPENTOLATE HYDROCHLORIDE; TROPICAMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredients Info: 10 mg/1 mL; 10 mg/1 mL; 25 mg/1 mL
History Active Ingredients Raw: CYCLOPENTOLATE HYDROCHLORIDE; TROPICAMIDE; PHENYLEPHRINE HYDROCHLORIDE
History Active Ingredients Info Raw: 10 mg/1 mL; 10 mg/1 mL; 25 mg/1 mL
History Dosage Raw: SOLUTION/ DROPS
Dea Schedule: [empty]
Package Ndc Raw: 71449-092-46
Package Ndc: 71449-092-46
Package Ndc Digits: 7144909246
Package Ndc11: 71449009246
Package Description: 1 BOTTLE, DROPPER in 1 BAG (71449-092-46) > 5 mL in 1 BOTTLE, DROPPER
Reporting Period Raw: 2025-2
Reporting Period: 2025-2
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:1749
Source Row Number: 1749
Source Row Hash: bb502b73d754d4fb9c667f150c020160b82ed380610ea97695f7738e7b0b8e4e
Import Run Id: 20261022T045816Z
Loaded At: 2026-10-22 05:03:38

Exact raw FDA source fields#

{
    "ROUTENAME": "OPHTHALMIC",
    "PRODUCTNDC": "71449-092",
    "DEASCHEDULE": "",
    "LABELERNAME": "Denver Solutions, LLC dba Leiters Health",
    "SUBSTANCENAME": "CYCLOPENTOLATE HYDROCHLORIDE; TROPICAMIDE; PHENYLEPHRINE HYDROCHLORIDE",
    "DOSAGEFORMNAME": "SOLUTION/ DROPS",
    "NDCPACKAGECODE": "71449-092-46",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Cyclopentolate Hydrochloride, Tropicamide, Phenylephrine Hydrochloride",
    "REPORTINGPERIOD": "2025-2",
    "NONPROPRIETARYNAME": "Cyclopentolate Hydrochloride, Tropicamide, Phenylephrine Hydrochloride",
    "PACKAGEDESCRIPTION": "1 BOTTLE, DROPPER in 1 BAG (71449-092-46)  > 5 mL in 1 BOTTLE, DROPPER",
    "ACTIVEINGREDIENTSINFO": "10 mg/1 mL; 10 mg/1 mL; 25 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:1749
Source Row Number: 1749
Status Scope: package
Lookup Ndc: 71449-092-46
Lookup Ndc Digits: 7144909246
Product Ndc: 71449-092
Product Ndc Digits: 71449092
Package Ndc: 71449-092-46
Package Ndc Digits: 7144909246
Package Ndc11: 71449009246
Product Id: [empty]
Status Code: COMPOUNDER
Status Label: Outsourcing facility compounded drug report
Reporting Period Raw: 2025-2
Reporting Period: 2025-2
Source Table: fda_ndc_aux_compounder
Source File: compounders_ndc_directory.txt
Source Date: 2026-09-18
Source Row Hash: bb502b73d754d4fb9c667f150c020160b82ed380610ea97695f7738e7b0b8e4e
Import Run Id: 20261022T045816Z
Loaded At: 2026-10-22 05:03:38