Current NDC auxiliary source row compounder:271

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: 54288-841
Product Ndc: 54288-841
Product Ndc Digits: 54288841
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Tirzepatide and Pyridoxine Hydrochloride Injection, 10 mg/mL and 10 mg/mL
Proprietary Name Suffix: [empty]
Nonproprietary Name: Tirzepatide and Pyridoxine Hydrochloride Injection, 10 mg/mL and 10 mg/mL
Dosage Form Name: INJECTION
Route Name: SUBCUTANEOUS
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: PYRIDOXINE HYDROCHLORIDE; TIRZEPATIDE
Active Ingredients Info: 10 mg/1 mL; 10 mg/1 mL
History Active Ingredients Raw: PYRIDOXINE HYDROCHLORIDE; TIRZEPATIDE
History Active Ingredients Info Raw: 10 mg/1 mL; 10 mg/1 mL
History Dosage Raw: INJECTION
Dea Schedule: [empty]
Package Ndc Raw: 54288-841-25
Package Ndc: 54288-841-25
Package Ndc Digits: 5428884125
Package Ndc11: 54288084125
Package Description: 25 VIAL in 1 CARTON (54288-841-25) > 1 mL in 1 VIAL (54288-841-01)
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:271
Source Row Number: 271
Source Row Hash: c1e9f59f015b453b5c986aa1e2eb58a08fd6e0f9d88d4251a2e431aef716eb88
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20

Exact raw FDA source fields#

{
    "ROUTENAME": "SUBCUTANEOUS",
    "PRODUCTNDC": "54288-841",
    "DEASCHEDULE": "",
    "LABELERNAME": "BPI Labs LLC",
    "SUBSTANCENAME": "PYRIDOXINE HYDROCHLORIDE; TIRZEPATIDE",
    "DOSAGEFORMNAME": "INJECTION",
    "NDCPACKAGECODE": "54288-841-25",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Tirzepatide and Pyridoxine Hydrochloride Injection, 10 mg/mL and 10 mg/mL",
    "REPORTINGPERIOD": "2026-1",
    "NONPROPRIETARYNAME": "Tirzepatide and Pyridoxine Hydrochloride Injection, 10 mg/mL and 10 mg/mL",
    "PACKAGEDESCRIPTION": "25 VIAL in 1 CARTON (54288-841-25)  > 1 mL in 1 VIAL (54288-841-01) ",
    "ACTIVEINGREDIENTSINFO": "10 mg/1 mL; 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:271
Source Row Number: 271
Status Scope: package
Lookup Ndc: 54288-841-25
Lookup Ndc Digits: 5428884125
Product Ndc: 54288-841
Product Ndc Digits: 54288841
Package Ndc: 54288-841-25
Package Ndc Digits: 5428884125
Package Ndc11: 54288084125
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: c1e9f59f015b453b5c986aa1e2eb58a08fd6e0f9d88d4251a2e431aef716eb88
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20