Current NDC auxiliary source row compounder:1602

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: 63037-100
Product Ndc: 63037-100
Product Ndc Digits: 63037100
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Fentanyl Citrate in 0.9 % Sodium Chloride
Proprietary Name Suffix: [empty]
Nonproprietary Name: Fentanyl Citrate in 0.9% Sodium Chloride Injection
Dosage Form Name: INJECTION
Route Name: INTRAVENOUS
Marketing Category Name: OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Name: Hikma Injectables USA Inc.
Establishment Name: Hikma Injectables USA Inc.
Establishment Fei: [empty]
Substance Name: FENTANYL CITRATE
Active Ingredients Info: 1000 ug/100 mL
History Active Ingredients Raw: FENTANYL CITRATE
History Active Ingredients Info Raw: 1000 ug/100 mL
History Dosage Raw: INJECTION
Dea Schedule: CII
Package Ndc Raw: 63037-100-05
Package Ndc: 63037-100-05
Package Ndc Digits: 6303710005
Package Ndc11: 63037010005
Package Description: 100 mL in 1 BAG (63037-100-05)
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:1602
Source Row Number: 1602
Source Row Hash: 98772ae7972fc50dee30ab3179b9b2cf128697ba9c6b9ff1726e46585b70d232
Import Run Id: 20261022T045816Z
Loaded At: 2026-10-22 05:03:38

Exact raw FDA source fields#

{
    "ROUTENAME": "INTRAVENOUS",
    "PRODUCTNDC": "63037-100",
    "DEASCHEDULE": "CII",
    "LABELERNAME": "Hikma Injectables USA Inc.",
    "SUBSTANCENAME": "FENTANYL CITRATE",
    "DOSAGEFORMNAME": "INJECTION",
    "NDCPACKAGECODE": "63037-100-05",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Fentanyl Citrate in 0.9 % Sodium Chloride",
    "REPORTINGPERIOD": "2025-2",
    "NONPROPRIETARYNAME": "Fentanyl Citrate in 0.9% Sodium Chloride Injection",
    "PACKAGEDESCRIPTION": "100 mL in 1 BAG (63037-100-05) ",
    "ACTIVEINGREDIENTSINFO": "1000 ug/100 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:1602
Source Row Number: 1602
Status Scope: package
Lookup Ndc: 63037-100-05
Lookup Ndc Digits: 6303710005
Product Ndc: 63037-100
Product Ndc Digits: 63037100
Package Ndc: 63037-100-05
Package Ndc Digits: 6303710005
Package Ndc11: 63037010005
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: 98772ae7972fc50dee30ab3179b9b2cf128697ba9c6b9ff1726e46585b70d232
Import Run Id: 20261022T045816Z
Loaded At: 2026-10-22 05:03:38