Current NDC auxiliary source row compounder:428

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: 54288-861
Product Ndc: 54288-861
Product Ndc Digits: 54288861
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Testosterone Cypionate Injection, 2000 mg/10 mL (200 mg/mL)
Proprietary Name Suffix: [empty]
Nonproprietary Name: Testosterone Cypionate Injection, 2000 mg/10 mL (200 mg/mL)
Dosage Form Name: INJECTION
Route Name: INTRAMUSCULAR
Marketing Category Name: OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Name: BPI Labs LLC
Establishment Name: BPI Labs LLC
Establishment Fei: [empty]
Substance Name: TESTOSTERONE CYPIONATE
Active Ingredients Info: 2000 mg/10 mL
History Active Ingredients Raw: TESTOSTERONE CYPIONATE
History Active Ingredients Info Raw: 2000 mg/10 mL
History Dosage Raw: INJECTION
Dea Schedule: CIII
Package Ndc Raw: 54288-861-10
Package Ndc: 54288-861-10
Package Ndc Digits: 5428886110
Package Ndc11: 54288086110
Package Description: 10 VIAL in 1 CARTON (54288-861-10) > 10 mL in 1 VIAL (54288-861-01)
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:428
Source Row Number: 428
Source Row Hash: 22bbc62d00b619a36ec47d0fc2f2673179320335a66f320a2186b37dc6dd9508
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20

Exact raw FDA source fields#

{
    "ROUTENAME": "INTRAMUSCULAR",
    "PRODUCTNDC": "54288-861",
    "DEASCHEDULE": "CIII",
    "LABELERNAME": "BPI Labs LLC",
    "SUBSTANCENAME": "TESTOSTERONE CYPIONATE",
    "DOSAGEFORMNAME": "INJECTION",
    "NDCPACKAGECODE": "54288-861-10",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Testosterone Cypionate Injection, 2000 mg/10 mL (200 mg/mL)",
    "REPORTINGPERIOD": "2026-1",
    "NONPROPRIETARYNAME": "Testosterone Cypionate Injection, 2000 mg/10 mL (200 mg/mL)",
    "PACKAGEDESCRIPTION": "10 VIAL in 1 CARTON (54288-861-10)  > 10 mL in 1 VIAL (54288-861-01) ",
    "ACTIVEINGREDIENTSINFO": "2000 mg/10 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:428
Source Row Number: 428
Status Scope: package
Lookup Ndc: 54288-861-10
Lookup Ndc Digits: 5428886110
Product Ndc: 54288-861
Product Ndc Digits: 54288861
Package Ndc: 54288-861-10
Package Ndc Digits: 5428886110
Package Ndc11: 54288086110
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: 22bbc62d00b619a36ec47d0fc2f2673179320335a66f320a2186b37dc6dd9508
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20