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 4 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CITALOPRAM HYDROBROMIDECITALOPRAMExelan Pharmaceuticals Inc.a8e8fde2-8392-4d5b-902b-e2b9dd55a02d2024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals, Inc.4f45c818-b324-6ca6-e054-00144ff8d46c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078216
rxcui: 200371
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.579836d8-64ed-de2d-e053-2a91aa0a83922024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078216
rxcui: 200371
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.549a5b3f-4928-1ae5-e054-00144ff8d46c2024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078216
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDEQUALLENT PHARMACEUTICALS HEALTH LLCe0822069-9672-4d4c-bc1a-8739b0dd045c2024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMMylan Pharmaceuticals Inc.825c0c49-5fbf-6d8b-cb8c-94ebf0eda0432024-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.9987a273-e6d7-54cd-e053-2a95a90a0aaa2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078216
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDEAurobindo Pharma Limited2632b547-2e13-447f-ac85-c774e437d6a82024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEAurobindo Pharma Limitede7a2cbdd-1bdb-4e59-a3dd-298a189753ae2024-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I1E9D14F36
CitalopramCITALOPRAMA-S Medication Solutionsc91684c7-fddb-4cf0-9711-b0484c8c7e8b2024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAMA-S Medication Solutions17af7a8d-ef57-4253-96ed-e457e0062eb52024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMA-S Medication Solutions04ac5286-fc2e-4990-a574-ea21131ef7312024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsfc766b76-18c1-42cd-b276-f720f5821c112024-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDECamber Pharmaceuticals, Inc.dc7b3f88-ee55-4e3e-9ed4-fc06aa7620cc2024-02-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsc6730edc-7226-4521-a04a-1bf296b01b8d2024-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMNuCare Pharmaceuticals,Inc.0dfb11d9-f48d-56ee-e063-6294a90ad2562024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEA-S Medication Solutions9059c8f1-8755-492d-aba2-5f5088ce69d32023-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078216
rxcui: 309314
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEA-S Medication Solutions9d2f8f9f-9710-48e0-bc18-105a2af1073b2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078216
rxcui: 200371
unii: I1E9D14F36
CelexaCITALOPRAMAllergan, Inc.4259d9b1-de34-43a4-85a8-41dd214e91772023-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
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

Reported adverse events (FAERS/openFDA)#

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