Current NDC auxiliary source row compounder:809

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: 83826-9016
Product Ndc: 83826-9016
Product Ndc Digits: 838269016
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Prednisolone Phosphate, Moxifloxacin, Bromfenac
Proprietary Name Suffix: [empty]
Nonproprietary Name: Prednisolone Phosphate 1%, Moxifloxacin 0.5%, Bromfenac 0.075%
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: MOXIFLOXACIN HYDROCHLORIDE; PREDNISOLONE SODIUM PHOSPHATE; BROMFENAC SODIUM
Active Ingredients Info: 5 mg/1 mL; 10 mg/1 mL; .75 mg/1 mL
History Active Ingredients Raw: MOXIFLOXACIN HYDROCHLORIDE; PREDNISOLONE SODIUM PHOSPHATE; BROMFENAC SODIUM
History Active Ingredients Info Raw: 5 mg/1 mL; 10 mg/1 mL; .75 mg/1 mL
History Dosage Raw: SOLUTION
Dea Schedule: [empty]
Package Ndc Raw: 83826-9016-8
Package Ndc: 83826-9016-8
Package Ndc Digits: 8382690168
Package Ndc11: 83826901608
Package Description: 8 mL in 1 BOTTLE, DROPPER (83826-9016-8)
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:809
Source Row Number: 809
Source Row Hash: 946a2b17497d1345dd7f31f49e17c216f7a434b00a29134e27e6e977996de671
Import Run Id: 20261018T022251Z
Loaded At: 2026-10-18 02:29:51

Exact raw FDA source fields#

{
    "ROUTENAME": "OPHTHALMIC; TOPICAL",
    "PRODUCTNDC": "83826-9016",
    "DEASCHEDULE": "",
    "LABELERNAME": "OSRX, Inc.",
    "SUBSTANCENAME": "MOXIFLOXACIN HYDROCHLORIDE; PREDNISOLONE SODIUM PHOSPHATE; BROMFENAC SODIUM",
    "DOSAGEFORMNAME": "SOLUTION",
    "NDCPACKAGECODE": "83826-9016-8",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Prednisolone Phosphate, Moxifloxacin, Bromfenac",
    "REPORTINGPERIOD": "2025-1",
    "NONPROPRIETARYNAME": "Prednisolone Phosphate 1%, Moxifloxacin 0.5%, Bromfenac 0.075%",
    "PACKAGEDESCRIPTION": "8 mL in 1 BOTTLE, DROPPER (83826-9016-8) ",
    "ACTIVEINGREDIENTSINFO": "5 mg/1 mL; 10 mg/1 mL; .75 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:809
Source Row Number: 809
Status Scope: package
Lookup Ndc: 83826-9016-8
Lookup Ndc Digits: 8382690168
Product Ndc: 83826-9016
Product Ndc Digits: 838269016
Package Ndc: 83826-9016-8
Package Ndc Digits: 8382690168
Package Ndc11: 83826901608
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: 946a2b17497d1345dd7f31f49e17c216f7a434b00a29134e27e6e977996de671
Import Run Id: 20261018T022251Z
Loaded At: 2026-10-18 02:29:51