Current NDC auxiliary source row compounder:1276

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: 69761-101
Product Ndc: 69761-101
Product Ndc Digits: 69761101
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Estradiol / Stearic Acid
Proprietary Name Suffix: [empty]
Nonproprietary Name: Estradiol
Dosage Form Name: PELLET
Route Name: SUBCUTANEOUS
Marketing Category Name: OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Name: Qualgen LLC
Establishment Name: Qualgen LLC
Establishment Fei: [empty]
Substance Name: ESTRADIOL
Active Ingredients Info: 10 mg
History Active Ingredients Raw: ESTRADIOL
History Active Ingredients Info Raw: 10 mg
History Dosage Raw: PELLET
Dea Schedule: [empty]
Package Ndc Raw: 69761-101-01
Package Ndc: 69761-101-01
Package Ndc Digits: 6976110101
Package Ndc11: 69761010101
Package Description: 1 PELLET in 1 VIAL (69761-101-01)
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:1276
Source Row Number: 1276
Source Row Hash: f83de1bfcf90845e915edd94c3851be889c9cbefac02b8dbdbb7a79d9f7d8325
Import Run Id: 20261022T045816Z
Loaded At: 2026-10-22 05:03:38

Exact raw FDA source fields#

{
    "ROUTENAME": "SUBCUTANEOUS",
    "PRODUCTNDC": "69761-101",
    "DEASCHEDULE": "",
    "LABELERNAME": "Qualgen LLC",
    "SUBSTANCENAME": "ESTRADIOL",
    "DOSAGEFORMNAME": "PELLET",
    "NDCPACKAGECODE": "69761-101-01",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Estradiol / Stearic Acid",
    "REPORTINGPERIOD": "2025-2",
    "NONPROPRIETARYNAME": "Estradiol",
    "PACKAGEDESCRIPTION": "1 PELLET in 1 VIAL (69761-101-01) ",
    "ACTIVEINGREDIENTSINFO": "10 mg",
    "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:1276
Source Row Number: 1276
Status Scope: package
Lookup Ndc: 69761-101-01
Lookup Ndc Digits: 6976110101
Product Ndc: 69761-101
Product Ndc Digits: 69761101
Package Ndc: 69761-101-01
Package Ndc Digits: 6976110101
Package Ndc11: 69761010101
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: f83de1bfcf90845e915edd94c3851be889c9cbefac02b8dbdbb7a79d9f7d8325
Import Run Id: 20261022T045816Z
Loaded At: 2026-10-22 05:03:38