NDC 70518-1357-2 - Citalopram Hydrobromide

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
70518-1357
Requested NDC
70518-1357-2
Package NDCs from labels
70518-1357-0, 70518-1357-2, 70518-1357-1
Manufacturer
REMEDYREPACK INC.
Effective date
2025-02-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Citalopram Hydrobromide - REMEDYREPACK INC.REMEDYREPACK INC.2025-02-10HUMAN PRESCRIPTION DRUG LABEL

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 5 of 5 · 89 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CitalopramCITALOPRAM HYDROBROMIDENCS HealthCare of KY, LLC dba Vangard Labsfd761647-e16b-45b3-a4bc-364de0ed70152023-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMHikma Pharmaceuticals USA Inc.29408d84-7b00-4cee-969c-8095f8083ff52023-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEProficient Rx LP4eb71151-241a-476e-a495-4a021bc55bda2023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078216
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDEProficient Rx LPf37cc307-8b7d-4e5c-8beb-cd8779bc86a72022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMAphena Pharma Solutions - Tennessee, LLC3d70380f-ef97-4de9-a8f8-44ef9ba7e5a72020-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDEAphena Pharma Solutions - Tennessee, LLC31ddd184-7560-473c-b674-5fa3187c55982020-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMAphena Pharma Solutions - Tennessee, LLC0867140e-a483-4bf7-8326-4a9730cc9d9d2020-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDEProficient Rx LP289c1d5e-902f-47db-85b8-5e1a55ec86842019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
CITALOPRAM HYDROBROMIDECITALOPRAMAphena Pharma Solutions - Tennessee, LLCd05f4e71-95f3-4f22-8b01-b21e5c19e0f22018-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36

Reported adverse events (FAERS/openFDA)#

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