Current NDC auxiliary source row compounder:3003

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: 71506-046
Product Ndc: 71506-046
Product Ndc Digits: 71506046
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Labetalol Hydrochloride
Proprietary Name Suffix: [empty]
Nonproprietary Name: Labetalol Hydrochloride
Dosage Form Name: INJECTION
Route Name: INTRAVENOUS
Marketing Category Name: OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Name: Fresenius Kabi Compounding LLC DBA Fagron Sterile Services
Establishment Name: Fresenius Kabi Compounding LLC DBA Fagron Sterile Services
Establishment Fei: [empty]
Substance Name: LABETALOL HYDROCHLORIDE
Active Ingredients Info: 20 mg/4 mL
History Active Ingredients Raw: LABETALOL HYDROCHLORIDE
History Active Ingredients Info Raw: 20 mg/4 mL
History Dosage Raw: INJECTION
Dea Schedule: [empty]
Package Ndc Raw: 71506-046-45
Package Ndc: 71506-046-45
Package Ndc Digits: 7150604645
Package Ndc11: 71506004645
Package Description: 4 mL in 1 SYRINGE (71506-046-45)
Reporting Period Raw: 2025-1
Reporting Period: 2025-1
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:3003
Source Row Number: 3003
Source Row Hash: 6891c4d799adbab66e2ff19104fac3f4211ad38a4f650c74c530ca85f8658646
Import Run Id: 20261024T140201Z
Loaded At: 2026-10-24 14:07:01

Exact raw FDA source fields#

{
    "ROUTENAME": "INTRAVENOUS",
    "PRODUCTNDC": "71506-046",
    "DEASCHEDULE": "",
    "LABELERNAME": "Fresenius Kabi Compounding LLC DBA Fagron Sterile Services",
    "SUBSTANCENAME": "LABETALOL HYDROCHLORIDE",
    "DOSAGEFORMNAME": "INJECTION",
    "NDCPACKAGECODE": "71506-046-45",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Labetalol Hydrochloride",
    "REPORTINGPERIOD": "2025-1",
    "NONPROPRIETARYNAME": "Labetalol Hydrochloride",
    "PACKAGEDESCRIPTION": "4 mL in 1 SYRINGE (71506-046-45) ",
    "ACTIVEINGREDIENTSINFO": "20 mg/4 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:3003
Source Row Number: 3003
Status Scope: package
Lookup Ndc: 71506-046-45
Lookup Ndc Digits: 7150604645
Product Ndc: 71506-046
Product Ndc Digits: 71506046
Package Ndc: 71506-046-45
Package Ndc Digits: 7150604645
Package Ndc11: 71506004645
Product Id: [empty]
Status Code: COMPOUNDER
Status Label: Outsourcing facility compounded drug report
Reporting Period Raw: 2025-1
Reporting Period: 2025-1
Source Table: fda_ndc_aux_compounder
Source File: compounders_ndc_directory.txt
Source Date: 2026-09-18
Source Row Hash: 6891c4d799adbab66e2ff19104fac3f4211ad38a4f650c74c530ca85f8658646
Import Run Id: 20261024T140201Z
Loaded At: 2026-10-24 14:07:01