FDA.reportPublic FDA data

NDC 0409-1902-11 - Procainamide Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0409-1902
Requested NDC
0409-1902-11
Package NDCs from labels
0409-1902-11, 0409-1902-01
Manufacturer
Hospira, Inc.
Effective date
2026-07-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PROCAINAMIDE HYDROCHLORIDEHospira, Inc.2026-07-08HUMAN PRESCRIPTION DRUG LABEL
PROCAINAMIDE HCI - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-02-19HUMAN PRESCRIPTION DRUG LABEL
Procainamide Hydrochloride - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-11-21HUMAN PRESCRIPTION DRUG LABEL
Procainamide Hydrochloride - McKesson CorporationMcKesson Corporation2018-03-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1902-01Procainamide Hydrochloride25 in 1 CASEINJECTION, SOLUTION2525
0409-1902-11Procainamide Hydrochloride10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1025
0409-1902-11Procainamide Hydrochloride1 in 1 CARTONINJECTION, SOLUTION125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1902PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]24Current NDC, Legacy NDC, 3 package rows20230629_17e47845-daad-434c-a784-6d3875b0d704.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1902-01ML - Milliliter0409-1902b5bb6da4-8bb6-48a9-8ae2-097ed82e95ac12012-07-24
0409-1902-11ML - Milliliter0409-1902ec8f06c8-394b-4141-ae72-4183c976132c12020-03-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROCAINAMIDE HYDROCHLORIDEACTIVE INGREDIENTSI4064O0LXPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
PROCAINAMIDEACTIVE MOIETYL39WTC366DPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
WATERINACTIVE INGREDIENT059QF0KO0RPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
Procainamide HydrochlorideACTIVE INGREDIENTSI4064O0LXPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
ProcainamideACTIVE MOIETYL39WTC366DPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
Sodium MetabisulfiteINACTIVE INGREDIENT4VON5FNS3CPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 11 · 214 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEREMEDYREPACK INC.1ec3b767-66bb-4634-877e-71f70d501da02026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SI4064O0LX
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEHospira, Inc.17e47845-daad-434c-a784-6d3875b0d7042026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA089069
ndc (package): 0409-1902-11
ndc (package): 0409-1902-01
ndc (product): 0409-1902
ndc11 (package): 00409190211
rxcui: 857886
spl id: 8bd73868-f050-4ffb-9bb1-222be0bd3f0f
spl set id: 17e47845-daad-434c-a784-6d3875b0d704
unii: SI4064O0LX
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
PROCAINAMIDE HYDROCHLORIDEPROCAINAMIDE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstfece65c0-fdbc-61d8-e053-6294a90a9a682026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: SI4064O0LX
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.