Current NDC auxiliary source row compounder:1763

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: 68985-925
Product Ndc: 68985-925
Product Ndc Digits: 68985925
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Dexmedetomidine HCl 4mcg/mL
Proprietary Name Suffix: [empty]
Nonproprietary Name: Dexmedetomidine HCl IN 0.9% NaCl
Dosage Form Name: SOLUTION
Route Name: INTRAVENOUS
Marketing Category Name: OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Name: LEESAR INC
Establishment Name: LEESAR INC
Establishment Fei: [empty]
Substance Name: DEXMEDETOMIDINE HYDROCHLORIDE
Active Ingredients Info: 4 mg/1000 mL
History Active Ingredients Raw: DEXMEDETOMIDINE HYDROCHLORIDE
History Active Ingredients Info Raw: 4 mg/1000 mL
History Dosage Raw: SOLUTION
Dea Schedule: [empty]
Package Ndc Raw: 68985-925-96
Package Ndc: 68985-925-96
Package Ndc Digits: 6898592596
Package Ndc11: 68985092596
Package Description: 5 mL in 1 SYRINGE (68985-925-96)
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:1763
Source Row Number: 1763
Source Row Hash: 3700fa2e35f2e78fc24ba29d67975825db261edf287a4defb7acf73562c382bb
Import Run Id: 20261024T140201Z
Loaded At: 2026-10-24 14:07:01

Exact raw FDA source fields#

{
    "ROUTENAME": "INTRAVENOUS",
    "PRODUCTNDC": "68985-925",
    "DEASCHEDULE": "",
    "LABELERNAME": "LEESAR INC",
    "SUBSTANCENAME": "DEXMEDETOMIDINE HYDROCHLORIDE",
    "DOSAGEFORMNAME": "SOLUTION",
    "NDCPACKAGECODE": "68985-925-96",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Dexmedetomidine HCl 4mcg/mL",
    "REPORTINGPERIOD": "2026-1",
    "NONPROPRIETARYNAME": "Dexmedetomidine HCl IN 0.9% NaCl",
    "PACKAGEDESCRIPTION": "5 mL in 1 SYRINGE (68985-925-96) ",
    "ACTIVEINGREDIENTSINFO": "4 mg/1000 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:1763
Source Row Number: 1763
Status Scope: package
Lookup Ndc: 68985-925-96
Lookup Ndc Digits: 6898592596
Product Ndc: 68985-925
Product Ndc Digits: 68985925
Package Ndc: 68985-925-96
Package Ndc Digits: 6898592596
Package Ndc11: 68985092596
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: 3700fa2e35f2e78fc24ba29d67975825db261edf287a4defb7acf73562c382bb
Import Run Id: 20261024T140201Z
Loaded At: 2026-10-24 14:07:01