Current NDC auxiliary source row compounder:149

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: 71449-131
Product Ndc: 71449-131
Product Ndc Digits: 71449131
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Dexmedetomidine Hydrochloride
Proprietary Name Suffix: Preservative Free
Nonproprietary Name: Dexmedetomidine Hydrochloride
Dosage Form Name: INJECTION, SOLUTION
Route Name: INTRAVENOUS
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: DEXMEDETOMIDINE HYDROCHLORIDE
Active Ingredients Info: 4 ug/1 mL
History Active Ingredients Raw: DEXMEDETOMIDINE HYDROCHLORIDE
History Active Ingredients Info Raw: 4 ug/1 mL
History Dosage Raw: INJECTION, SOLUTION
Dea Schedule: [empty]
Package Ndc Raw: 71449-131-15
Package Ndc: 71449-131-15
Package Ndc Digits: 7144913115
Package Ndc11: 71449013115
Package Description: 5 SYRINGE, PLASTIC in 1 CONTAINER (71449-131-15) > 10 mL in 1 SYRINGE, PLASTIC
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:149
Source Row Number: 149
Source Row Hash: 50b342e5928a4d558524dc5764b1a332870e89b06bca99c30611361aae384a79
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20

Exact raw FDA source fields#

{
    "ROUTENAME": "INTRAVENOUS",
    "PRODUCTNDC": "71449-131",
    "DEASCHEDULE": "",
    "LABELERNAME": "Denver Solutions, LLC dba Leiters Health",
    "SUBSTANCENAME": "DEXMEDETOMIDINE HYDROCHLORIDE",
    "DOSAGEFORMNAME": "INJECTION, SOLUTION",
    "NDCPACKAGECODE": "71449-131-15",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Dexmedetomidine Hydrochloride",
    "REPORTINGPERIOD": "2025-1",
    "NONPROPRIETARYNAME": "Dexmedetomidine Hydrochloride",
    "PACKAGEDESCRIPTION": "5 SYRINGE, PLASTIC in 1 CONTAINER (71449-131-15)  > 10 mL in 1 SYRINGE, PLASTIC",
    "ACTIVEINGREDIENTSINFO": "4 ug/1 mL",
    "MARKETINGCATEGORYNAME": "OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)",
    "PROPRIETARYNAMESUFFIX": "Preservative Free"
}

Normalization notes#

[]

Current status projection#

Dataset: compounder
Record Source: ndc_compounder_zip
Source Record Id: compounder:149
Source Row Number: 149
Status Scope: package
Lookup Ndc: 71449-131-15
Lookup Ndc Digits: 7144913115
Product Ndc: 71449-131
Product Ndc Digits: 71449131
Package Ndc: 71449-131-15
Package Ndc Digits: 7144913115
Package Ndc11: 71449013115
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: 50b342e5928a4d558524dc5764b1a332870e89b06bca99c30611361aae384a79
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20