Current NDC auxiliary source row compounder:3073

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: 69194-947
Product Ndc: 69194-947
Product Ndc Digits: 69194947
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: 947 MDB DROPS 0.5%-0.1%-0.035% 5mL
Proprietary Name Suffix: [empty]
Nonproprietary Name: MOXIFLOXACIN 0.5%, DEXAMETHASONE 0.1%, BROMFENAC 0.035%
Dosage Form Name: SOLUTION
Route Name: OPHTHALMIC
Marketing Category Name: OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Name: Pine Pharmaceuticals LLC
Establishment Name: Pine Pharmaceuticals LLC
Establishment Fei: [empty]
Substance Name: BROMFENAC SODIUM; MOXIFLOXACIN HYDROCHLORIDE; DEXAMETHASONE SODIUM PHOSPHATE
Active Ingredients Info: .35 mg/1 mL; 5 mg/1 mL; 1 mg/1 mL
History Active Ingredients Raw: BROMFENAC SODIUM; MOXIFLOXACIN HYDROCHLORIDE; DEXAMETHASONE SODIUM PHOSPHATE
History Active Ingredients Info Raw: .35 mg/1 mL; 5 mg/1 mL; 1 mg/1 mL
History Dosage Raw: SOLUTION
Dea Schedule: [empty]
Package Ndc Raw: 69194-947-01
Package Ndc: 69194-947-01
Package Ndc Digits: 6919494701
Package Ndc11: 69194094701
Package Description: 5 mL in 1 BOTTLE, DROPPER (69194-947-01)
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:3073
Source Row Number: 3073
Source Row Hash: 4dd3a361a71feb9067adb1d21f5e60370200880209d9a9c75bca971208e18b93
Import Run Id: 20261025T224840Z
Loaded At: 2026-10-25 22:53:27

Exact raw FDA source fields#

{
    "ROUTENAME": "OPHTHALMIC",
    "PRODUCTNDC": "69194-947",
    "DEASCHEDULE": "",
    "LABELERNAME": "Pine Pharmaceuticals LLC",
    "SUBSTANCENAME": "BROMFENAC SODIUM; MOXIFLOXACIN HYDROCHLORIDE; DEXAMETHASONE SODIUM PHOSPHATE",
    "DOSAGEFORMNAME": "SOLUTION",
    "NDCPACKAGECODE": "69194-947-01",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "947 MDB DROPS 0.5%-0.1%-0.035% 5mL",
    "REPORTINGPERIOD": "2025-2",
    "NONPROPRIETARYNAME": "MOXIFLOXACIN 0.5%, DEXAMETHASONE 0.1%, BROMFENAC 0.035%",
    "PACKAGEDESCRIPTION": "5 mL in 1 BOTTLE, DROPPER (69194-947-01) ",
    "ACTIVEINGREDIENTSINFO": ".35 mg/1 mL; 5 mg/1 mL; 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:3073
Source Row Number: 3073
Status Scope: package
Lookup Ndc: 69194-947-01
Lookup Ndc Digits: 6919494701
Product Ndc: 69194-947
Product Ndc Digits: 69194947
Package Ndc: 69194-947-01
Package Ndc Digits: 6919494701
Package Ndc11: 69194094701
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: 4dd3a361a71feb9067adb1d21f5e60370200880209d9a9c75bca971208e18b93
Import Run Id: 20261025T224840Z
Loaded At: 2026-10-25 22:53:27