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 5 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CITALOPRAM HYDROBROMIDECITALOPRAMAphena Pharma Solutions - Tennessee, LLCd05f4e71-95f3-4f22-8b01-b21e5c19e0f22018-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
01A0C14D-9278-609A-7C18-EC571AAA64B5AFA26CDE-E512-48D1-A9AE-3E1CEE2F7F722008-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 01A0C14D-9278-609A-7C18-EC571AAA64B5
spl set id: AFA26CDE-E512-48D1-A9AE-3E1CEE2F7F72

Reported adverse events (FAERS/openFDA)#

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