Current NDC auxiliary source row compounder:1373

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: 68985-153
Product Ndc: 68985-153
Product Ndc Digits: 68985153
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Amiodarone 900mg
Proprietary Name Suffix: [empty]
Nonproprietary Name: Amiodarone 900mg
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: AMIODARONE HYDROCHLORIDE
Active Ingredients Info: 1.8 mg/1 mL
History Active Ingredients Raw: AMIODARONE HYDROCHLORIDE
History Active Ingredients Info Raw: 1.8 mg/1 mL
History Dosage Raw: SOLUTION
Dea Schedule: [empty]
Package Ndc Raw: 68985-153-85
Package Ndc: 68985-153-85
Package Ndc Digits: 6898515385
Package Ndc11: 68985015385
Package Description: 500 mL in 1 BAG (68985-153-85)
Reporting Period Raw: 2024-2
Reporting Period: 2024-2
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:1373
Source Row Number: 1373
Source Row Hash: 5bab38599534cd03f9c6ba4b7f098bbd5204c12852c77fa1b9992d510c1848f1
Import Run Id: 20261022T045816Z
Loaded At: 2026-10-22 05:03:38

Exact raw FDA source fields#

{
    "ROUTENAME": "INTRAVENOUS",
    "PRODUCTNDC": "68985-153",
    "DEASCHEDULE": "",
    "LABELERNAME": "LEESAR INC",
    "SUBSTANCENAME": "AMIODARONE HYDROCHLORIDE",
    "DOSAGEFORMNAME": "SOLUTION",
    "NDCPACKAGECODE": "68985-153-85",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Amiodarone 900mg",
    "REPORTINGPERIOD": "2024-2",
    "NONPROPRIETARYNAME": "Amiodarone 900mg",
    "PACKAGEDESCRIPTION": "500 mL in 1 BAG (68985-153-85) ",
    "ACTIVEINGREDIENTSINFO": "1.8 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:1373
Source Row Number: 1373
Status Scope: package
Lookup Ndc: 68985-153-85
Lookup Ndc Digits: 6898515385
Product Ndc: 68985-153
Product Ndc Digits: 68985153
Package Ndc: 68985-153-85
Package Ndc Digits: 6898515385
Package Ndc11: 68985015385
Product Id: [empty]
Status Code: COMPOUNDER
Status Label: Outsourcing facility compounded drug report
Reporting Period Raw: 2024-2
Reporting Period: 2024-2
Source Table: fda_ndc_aux_compounder
Source File: compounders_ndc_directory.txt
Source Date: 2026-09-18
Source Row Hash: 5bab38599534cd03f9c6ba4b7f098bbd5204c12852c77fa1b9992d510c1848f1
Import Run Id: 20261022T045816Z
Loaded At: 2026-10-22 05:03:38