FDA.reportPublic FDA data

NDC 0591-3176 - 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
0591-3176
Package NDCs from labels
0591-3176-01, 0591-3176-05
Manufacturer
Watson Laboratories, Inc
Effective date
2008-01-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Citalopram Hydrobromide - Watson Laboratories, IncWatson Laboratories, Inc2008-01-17HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-3176-01Citalopram Hydrobromide100 in 1 BOTTLETABLET1004
0591-3176-05Citalopram Hydrobromide500 in 1 BOTTLETABLET5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3176CITALOPRAM HYDROBROMIDE (CITALOPRAM HYDROBROMIDE) TABLET [WATSON LABORATORIES, INC]42 package rows20080125_AFA26CDE-E512-48D1-A9AE-3E1CEE2F7F72.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE (CITALOPRAM HYDROBROMIDE) TABLET [WATSON LABORATORIES, INC]4
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE (CITALOPRAM HYDROBROMIDE) TABLET [WATSON LABORATORIES, INC]4
corn starchINACTIVE INGREDIENTCITALOPRAM HYDROBROMIDE (CITALOPRAM HYDROBROMIDE) TABLET [WATSON LABORATORIES, INC]4
croscarmellose sodiumINACTIVE INGREDIENTCITALOPRAM HYDROBROMIDE (CITALOPRAM HYDROBROMIDE) TABLET [WATSON LABORATORIES, INC]4
hypromelloseINACTIVE INGREDIENTCITALOPRAM HYDROBROMIDE (CITALOPRAM HYDROBROMIDE) TABLET [WATSON LABORATORIES, INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM HYDROBROMIDE (CITALOPRAM HYDROBROMIDE) TABLET [WATSON LABORATORIES, INC]4
MANNITOLINACTIVE INGREDIENT3OWL53L36ACITALOPRAM HYDROBROMIDE (CITALOPRAM HYDROBROMIDE) TABLET [WATSON LABORATORIES, INC]4
microcrystalline celluloseINACTIVE INGREDIENTCITALOPRAM HYDROBROMIDE (CITALOPRAM HYDROBROMIDE) TABLET [WATSON LABORATORIES, INC]4
polyethylene glycolINACTIVE INGREDIENTCITALOPRAM HYDROBROMIDE (CITALOPRAM HYDROBROMIDE) TABLET [WATSON LABORATORIES, INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM HYDROBROMIDE (CITALOPRAM HYDROBROMIDE) TABLET [WATSON LABORATORIES, INC]4

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 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CitalopramCITALOPRAM HYDROBROMIDEQUALLENT PHARMACEUTICALS HEALTH LLCe0822069-9672-4d4c-bc1a-8739b0dd045c2024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
CitalopramCITALOPRAMMylan Pharmaceuticals Inc.825c0c49-5fbf-6d8b-cb8c-94ebf0eda0432024-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.9987a273-e6d7-54cd-e053-2a95a90a0aaa2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
CitalopramCITALOPRAM HYDROBROMIDEAurobindo Pharma Limited2632b547-2e13-447f-ac85-c774e437d6a82024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
CitalopramCITALOPRAMA-S Medication Solutionsc91684c7-fddb-4cf0-9711-b0484c8c7e8b2024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
CitalopramCITALOPRAMA-S Medication Solutions17af7a8d-ef57-4253-96ed-e457e0062eb52024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
CitalopramCITALOPRAMA-S Medication Solutions04ac5286-fc2e-4990-a574-ea21131ef7312024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsfc766b76-18c1-42cd-b276-f720f5821c112024-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsc6730edc-7226-4521-a04a-1bf296b01b8d2024-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
CitalopramCITALOPRAMNuCare Pharmaceuticals,Inc.0dfb11d9-f48d-56ee-e063-6294a90ad2562024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEA-S Medication Solutions9059c8f1-8755-492d-aba2-5f5088ce69d32023-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEA-S Medication Solutions9d2f8f9f-9710-48e0-bc18-105a2af1073b2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
CelexaCITALOPRAMAllergan, Inc.4259d9b1-de34-43a4-85a8-41dd214e91772023-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
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
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEProficient Rx LP4eb71151-241a-476e-a495-4a021bc55bda2023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
CitalopramCITALOPRAM HYDROBROMIDEProficient Rx LPf37cc307-8b7d-4e5c-8beb-cd8779bc86a72022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
CitalopramCITALOPRAMAphena Pharma Solutions - Tennessee, LLC3d70380f-ef97-4de9-a8f8-44ef9ba7e5a72020-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
CitalopramCITALOPRAM HYDROBROMIDEAphena Pharma Solutions - Tennessee, LLC31ddd184-7560-473c-b674-5fa3187c55982020-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
CitalopramCITALOPRAMAphena Pharma Solutions - Tennessee, LLC0867140e-a483-4bf7-8326-4a9730cc9d9d2020-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
CitalopramCITALOPRAM HYDROBROMIDEProficient Rx LP289c1d5e-902f-47db-85b8-5e1a55ec86842019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371

Reported adverse events (FAERS/openFDA)#

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