Current NDC auxiliary source row compounder:101

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: 82396-164
Product Ndc: 82396-164
Product Ndc Digits: 82396164
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Oxycodone Hydrochloride
Proprietary Name Suffix: [empty]
Nonproprietary Name: Oxycodone Hydrochloride
Dosage Form Name: SOLUTION, CONCENTRATE
Route Name: ORAL
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: OXYCODONE HYDROCHLORIDE
Active Ingredients Info: 20 mg/1 mL
History Active Ingredients Raw: OXYCODONE HYDROCHLORIDE
History Active Ingredients Info Raw: 20 mg/1 mL
History Dosage Raw: SOLUTION, CONCENTRATE
Dea Schedule: CII
Package Ndc Raw: 82396-164-25
Package Ndc: 82396-164-25
Package Ndc Digits: 8239616425
Package Ndc11: 82396016425
Package Description: .25 mL in 1 SYRINGE, PLASTIC (82396-164-25)
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:101
Source Row Number: 101
Source Row Hash: 235d4c0bc4e9d6e72bd06393092b8a41b61cefa665b84c6d263299312c1157a1
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20

Exact raw FDA source fields#

{
    "ROUTENAME": "ORAL",
    "PRODUCTNDC": "82396-164",
    "DEASCHEDULE": "CII",
    "LABELERNAME": "ANNOVEX PHARMA, INC.",
    "SUBSTANCENAME": "OXYCODONE HYDROCHLORIDE",
    "DOSAGEFORMNAME": "SOLUTION, CONCENTRATE",
    "NDCPACKAGECODE": "82396-164-25",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Oxycodone Hydrochloride",
    "REPORTINGPERIOD": "2026-1",
    "NONPROPRIETARYNAME": "Oxycodone Hydrochloride",
    "PACKAGEDESCRIPTION": ".25 mL in 1 SYRINGE, PLASTIC (82396-164-25) ",
    "ACTIVEINGREDIENTSINFO": "20 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:101
Source Row Number: 101
Status Scope: package
Lookup Ndc: 82396-164-25
Lookup Ndc Digits: 8239616425
Product Ndc: 82396-164
Product Ndc Digits: 82396164
Package Ndc: 82396-164-25
Package Ndc Digits: 8239616425
Package Ndc11: 82396016425
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: 235d4c0bc4e9d6e72bd06393092b8a41b61cefa665b84c6d263299312c1157a1
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20