Current NDC auxiliary source row compounder:448

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: 71449-018
Product Ndc: 71449-018
Product Ndc Digits: 71449018
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Hydromorphone
Proprietary Name Suffix: [empty]
Nonproprietary Name: Hydromorphone
Dosage Form Name: INJECTION, SOLUTION
Route Name: INTRAVENOUS
Marketing Category Name: OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Name: Denver Solutions, LLC dba Leiters Health
Establishment Name: Denver Solutions, LLC dba Leiters Health
Establishment Fei: [empty]
Substance Name: HYDROMORPHONE
Active Ingredients Info: 1 mg/1 mL
History Active Ingredients Raw: HYDROMORPHONE
History Active Ingredients Info Raw: 1 mg/1 mL
History Dosage Raw: INJECTION, SOLUTION
Dea Schedule: CII
Package Ndc Raw: 71449-018-32
Package Ndc: 71449-018-32
Package Ndc Digits: 7144901832
Package Ndc11: 71449001832
Package Description: 30 mL in 1 SYRINGE, PLASTIC (71449-018-32)
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:448
Source Row Number: 448
Source Row Hash: 87dcafc1edc08a3819c176d4d992c73a0389a07f912f755996de0aaec51358da
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20

Exact raw FDA source fields#

{
    "ROUTENAME": "INTRAVENOUS",
    "PRODUCTNDC": "71449-018",
    "DEASCHEDULE": "CII",
    "LABELERNAME": "Denver Solutions, LLC dba Leiters Health",
    "SUBSTANCENAME": "HYDROMORPHONE",
    "DOSAGEFORMNAME": "INJECTION, SOLUTION",
    "NDCPACKAGECODE": "71449-018-32",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Hydromorphone",
    "REPORTINGPERIOD": "2025-2",
    "NONPROPRIETARYNAME": "Hydromorphone",
    "PACKAGEDESCRIPTION": "30 mL in 1 SYRINGE, PLASTIC (71449-018-32) ",
    "ACTIVEINGREDIENTSINFO": "1 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:448
Source Row Number: 448
Status Scope: package
Lookup Ndc: 71449-018-32
Lookup Ndc Digits: 7144901832
Product Ndc: 71449-018
Product Ndc Digits: 71449018
Package Ndc: 71449-018-32
Package Ndc Digits: 7144901832
Package Ndc11: 71449001832
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: 87dcafc1edc08a3819c176d4d992c73a0389a07f912f755996de0aaec51358da
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20