Current NDC auxiliary source row compounder:438

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: 69194-138
Product Ndc: 69194-138
Product Ndc Digits: 69194138
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: 138 BUPIVACAINE HCL 0.375%, LIDOCAINE HCl 2% SYRINGE
Proprietary Name Suffix: [empty]
Nonproprietary Name: bupivacaine HCL, lidocaine HCl
Dosage Form Name: INJECTION, SOLUTION
Route Name: RETROBULBAR
Marketing Category Name: OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Name: Pine Pharmaceuticals LLC
Establishment Name: Pine Pharmaceuticals LLC
Establishment Fei: [empty]
Substance Name: BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE
Active Ingredients Info: 3.75 mg/1 mL; 20 mg/1 mL
History Active Ingredients Raw: BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE
History Active Ingredients Info Raw: 3.75 mg/1 mL; 20 mg/1 mL
History Dosage Raw: INJECTION, SOLUTION
Dea Schedule: [empty]
Package Ndc Raw: 69194-138-01
Package Ndc: 69194-138-01
Package Ndc Digits: 6919413801
Package Ndc11: 69194013801
Package Description: 5 mL in 1 SYRINGE (69194-138-01)
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:438
Source Row Number: 438
Source Row Hash: 4b011ebfb936d2da5c54dcc8f2a6244b08f9345e16f99a43a01069b0c2feee00
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20

Exact raw FDA source fields#

{
    "ROUTENAME": "RETROBULBAR",
    "PRODUCTNDC": "69194-138",
    "DEASCHEDULE": "",
    "LABELERNAME": "Pine Pharmaceuticals LLC",
    "SUBSTANCENAME": "BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE",
    "DOSAGEFORMNAME": "INJECTION, SOLUTION",
    "NDCPACKAGECODE": "69194-138-01",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "138 BUPIVACAINE HCL 0.375%, LIDOCAINE HCl 2% SYRINGE",
    "REPORTINGPERIOD": "2026-1",
    "NONPROPRIETARYNAME": "bupivacaine HCL, lidocaine HCl",
    "PACKAGEDESCRIPTION": "5 mL in 1 SYRINGE (69194-138-01) ",
    "ACTIVEINGREDIENTSINFO": "3.75 mg/1 mL; 20 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:438
Source Row Number: 438
Status Scope: package
Lookup Ndc: 69194-138-01
Lookup Ndc Digits: 6919413801
Product Ndc: 69194-138
Product Ndc Digits: 69194138
Package Ndc: 69194-138-01
Package Ndc Digits: 6919413801
Package Ndc11: 69194013801
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: 4b011ebfb936d2da5c54dcc8f2a6244b08f9345e16f99a43a01069b0c2feee00
Import Run Id: 20261015T162751Z
Loaded At: 2026-10-15 16:32:20