FDA.reportPublic FDA data

Application 089537

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROCAINAMIDE HYDROCHLORIDEPROCAINAMIDE HYDROCHLORIDEINJECTABLE;INJECTION500MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089537-001PROCAINAMIDE HYDROCHLORIDEPROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTION1987-08-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A089537-001PROCAINAMIDE HYDROCHLORIDE500MG/MLINJECTABLE / INJECTION1987-08-25a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEHospira, Inc.17e47845-daad-434c-a784-6d3875b0d7042026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
PROCAINAMIDE HYDROCHLORIDEPROCAINAMIDE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstfece65c0-fdbc-61d8-e053-6294a90a9a682026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCAINAMIDE HYDROCHLORIDE
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDENexus Pharmaceuticals LLCd58751df-cd8b-45a6-8a32-af19e747e23a2025-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEMedical Purchasing Solutions, LLC.42405567-3d04-7aec-e063-6294a90aba0a2025-10-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEREMEDYREPACK INC.1ec3b767-66bb-4634-877e-71f70d501da02025-09-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEProPharma Distribution3d5d9d6e-1f1c-7565-e063-6394a90a93e72025-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDECaplin Steriles Limitedfcaa5e9a-3c8a-4796-aa87-626268b6cf602025-02-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDESagent Pharmaceuticals358c956e-8c6c-4bd6-a6bc-194d5b3d6d9a2024-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEGland Pharma Limitedffde440f-7ad7-434c-bcd2-9bd8ff16d2042024-07-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEMedical Purchasing Solutions, LLC0aac32fa-37b7-5520-e063-6394a90a1fe42023-11-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEInternational Medication Systems, Limitedd7cb1594-61cf-41c4-9007-1ee28aa69c502016-12-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE