FDA.reportPublic FDA data

NDC 50090-3208-01 - 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
50090-3208
Requested NDC
50090-3208-01
Package NDCs from labels
50090-3208-1, 50090-3208-2, 50090-3208-0, 50090-3208-01
Manufacturer
A-S Medication Solutions
Effective date
2024-09-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Citalopram Hydrobromide - A-S Medication SolutionsA-S Medication Solutions2024-09-18HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-3208-02023-02-07These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
50090-3208-12023-02-07These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
50090-3208-22023-02-07These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
50090-3208-02023-01-30These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
50090-3208-12023-01-30These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
50090-3208-22023-01-30These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3208-0Citalopram Hydrobromide30 in 1 BOTTLETABLET3032
50090-3208-1Citalopram Hydrobromide100 in 1 BOTTLETABLET10032
50090-3208-2Citalopram Hydrobromide90 in 1 BOTTLETABLET9032

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3208CITALOPRAM HYDROBROMIDE TABLET [A-S MEDICATION SOLUTIONS]32Current NDC, Legacy NDC, 3 package rows20240926_05421bee-f746-418e-bb9c-ab44a89b567d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3208-0EA - Each50090-320805469346-320e-4310-8f69-4a480059f65a12018-12-13
50090-3208-1EA - Each50090-32084fae9114-9077-40af-b1cc-ccebecd7aa2412018-12-13
50090-3208-2EA - Each50090-32081be49507-98a5-4fdd-a532-618a28a1170912018-12-13

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 · 88 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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.