Current NDC auxiliary source row compounder:302

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: 82396-127
Product Ndc: 82396-127
Product Ndc Digits: 82396127
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Esmolol Hydrochloride
Proprietary Name Suffix: [empty]
Nonproprietary Name: Esmolol Hydrochloride
Dosage Form Name: INJECTION, SOLUTION
Route Name: INTRAVENOUS
Marketing Category Name: OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Name: ANNOVEX PHARMA, INC.
Establishment Name: ANNOVEX PHARMA, INC.
Establishment Fei: [empty]
Substance Name: ESMOLOL HYDROCHLORIDE
Active Ingredients Info: 10 mg/1 mL
History Active Ingredients Raw: ESMOLOL HYDROCHLORIDE
History Active Ingredients Info Raw: 10 mg/1 mL
History Dosage Raw: INJECTION, SOLUTION
Dea Schedule: [empty]
Package Ndc Raw: 82396-127-10
Package Ndc: 82396-127-10
Package Ndc Digits: 8239612710
Package Ndc11: 82396012710
Package Description: 10 mL in 1 SYRINGE, PLASTIC (82396-127-10)
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:302
Source Row Number: 302
Source Row Hash: 95c9569ee21bd5204761a673214920ae7630f301aece3fe7dee08891a613ab73
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20

Exact raw FDA source fields#

{
    "ROUTENAME": "INTRAVENOUS",
    "PRODUCTNDC": "82396-127",
    "DEASCHEDULE": "",
    "LABELERNAME": "ANNOVEX PHARMA, INC.",
    "SUBSTANCENAME": "ESMOLOL HYDROCHLORIDE",
    "DOSAGEFORMNAME": "INJECTION, SOLUTION",
    "NDCPACKAGECODE": "82396-127-10",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Esmolol Hydrochloride",
    "REPORTINGPERIOD": "2025-2",
    "NONPROPRIETARYNAME": "Esmolol Hydrochloride",
    "PACKAGEDESCRIPTION": "10 mL in 1 SYRINGE, PLASTIC (82396-127-10) ",
    "ACTIVEINGREDIENTSINFO": "10 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:302
Source Row Number: 302
Status Scope: package
Lookup Ndc: 82396-127-10
Lookup Ndc Digits: 8239612710
Product Ndc: 82396-127
Product Ndc Digits: 82396127
Package Ndc: 82396-127-10
Package Ndc Digits: 8239612710
Package Ndc11: 82396012710
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: 95c9569ee21bd5204761a673214920ae7630f301aece3fe7dee08891a613ab73
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20