Current NDC auxiliary source row compounder:467

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: 70092-440
Product Ndc: 70092-440
Product Ndc Digits: 70092440
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Fent2mcg/mL-Rop0.2% PF200mlNS CADD-YFSFF
Proprietary Name Suffix: [empty]
Nonproprietary Name: Fent2mcg/mL-Rop0.2% PF200mlNS CADD-YFSFF
Dosage Form Name: INJECTION
Route Name: EPIDURAL
Marketing Category Name: OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Name: QuVa Pharma, Inc.
Establishment Name: QuVa Pharma, Inc.
Establishment Fei: [empty]
Substance Name: ROPIVACAINE HYDROCHLORIDE; FENTANYL CITRATE
Active Ingredients Info: 400 mg/200 mL; 400 ug/200 mL
History Active Ingredients Raw: ROPIVACAINE HYDROCHLORIDE; FENTANYL CITRATE
History Active Ingredients Info Raw: 400 mg/200 mL; 400 ug/200 mL
History Dosage Raw: INJECTION
Dea Schedule: CII
Package Ndc Raw: 70092-440-76
Package Ndc: 70092-440-76
Package Ndc Digits: 7009244076
Package Ndc11: 70092044076
Package Description: 200 mL in 1 CARTRIDGE (70092-440-76)
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:467
Source Row Number: 467
Source Row Hash: b41620a97dc211ef8d0d5b302ee48889b41faa3e9aa36db863cdec9ff907f700
Import Run Id: 20261018T022251Z
Loaded At: 2026-10-18 02:29:51

Exact raw FDA source fields#

{
    "ROUTENAME": "EPIDURAL",
    "PRODUCTNDC": "70092-440",
    "DEASCHEDULE": "CII",
    "LABELERNAME": "QuVa Pharma, Inc.",
    "SUBSTANCENAME": "ROPIVACAINE HYDROCHLORIDE; FENTANYL CITRATE",
    "DOSAGEFORMNAME": "INJECTION",
    "NDCPACKAGECODE": "70092-440-76",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Fent2mcg/mL-Rop0.2% PF200mlNS CADD-YFSFF",
    "REPORTINGPERIOD": "2025-2",
    "NONPROPRIETARYNAME": "Fent2mcg/mL-Rop0.2% PF200mlNS CADD-YFSFF",
    "PACKAGEDESCRIPTION": "200 mL in 1 CARTRIDGE (70092-440-76) ",
    "ACTIVEINGREDIENTSINFO": "400 mg/200 mL; 400 ug/200 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:467
Source Row Number: 467
Status Scope: package
Lookup Ndc: 70092-440-76
Lookup Ndc Digits: 7009244076
Product Ndc: 70092-440
Product Ndc Digits: 70092440
Package Ndc: 70092-440-76
Package Ndc Digits: 7009244076
Package Ndc11: 70092044076
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: b41620a97dc211ef8d0d5b302ee48889b41faa3e9aa36db863cdec9ff907f700
Import Run Id: 20261018T022251Z
Loaded At: 2026-10-18 02:29:51