FDA.reportPublic FDA data

NDC 0591-3178 - 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
0591-3178
Package NDCs from labels
0591-3178-01, 0591-3178-05, 0591-3178-44
Manufacturer
Contract Pharmacy Services-PA
Effective date
2010-02-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Citalopram Hydrobromide - Contract Pharmacy Services-PAContract Pharmacy Services-PA2010-02-25HUMAN PRESCRIPTION DRUG LABEL
Citalopram Hydrobromide - Watson Laboratories, IncWatson Laboratories, Inc2008-01-17HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-3178-01Citalopram Hydrobromide100 in 1 BOTTLETABLET1004
0591-3178-05Citalopram Hydrobromide500 in 1 BOTTLETABLET5004
0591-3178-44Citalopram Hydrobromide100 in 1 BLISTER PACKTABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3178CITALOPRAM HYDROBROMIDE (CITALOPRAM HYDROBROMIDE) TABLET [WATSON LABORATORIES, INC]43 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
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM HYDROBROMIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM HYDROBROMIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCITALOPRAM HYDROBROMIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM HYDROBROMIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ACITALOPRAM HYDROBROMIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM HYDROBROMIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM HYDROBROMIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM HYDROBROMIDE TABLET [CONTRACT PHARMACY SERVICES-PA]1

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 84 of 106 · 2,119 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
Essential Sheer SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.2132dc18-85ee-4449-86d2-d9f698f286c62024-07-31WarningsExact identifier
unii: 15FIX9V2JP
Proceuticals Private Label by TiZO tinted foaming mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd1e78109f-4d2e-2705-e063-6294a90a5ad32024-07-30WarningsExact identifier
unii: 15FIX9V2JP
Replenix Sheer SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.37d1f454-3bc9-4ce5-863c-0d4f6fa18fb42024-07-29WarningsExact identifier
unii: 15FIX9V2JP
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals, Inc.4f45c818-b324-6ca6-e054-00144ff8d46c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
Derma E Sun Defense Face SPF 30ZINC OXIDE TITANIUM DIOXIDEderma ed90b8f81-de7a-4022-800a-90f063e941802024-07-17WarningsExact identifier
unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1d611494-648b-6e5f-e063-6294a90a45002024-07-16WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8df98d97-a5d2-4d52-8bd2-130a13501d602024-07-16WarningsExact identifier
unii: 15FIX9V2JP
Derma E Sun Defense SPF 30ZINC OXIDE AND TITANIUM DIOXIDEderma e395b73a4-dae7-49da-9dab-ab622117c8c02024-07-12WarningsExact identifier
unii: 15FIX9V2JP
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.579836d8-64ed-de2d-e053-2a91aa0a83922024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1ce8c1da-565d-5487-e063-6294a90a1bde2024-07-10WarningsExact identifier
unii: 15FIX9V2JP
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.549a5b3f-4928-1ae5-e054-00144ff8d46c2024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1cc19337-cf54-af5d-e063-6394a90a1ceb2024-07-08WarningsExact identifier
unii: 15FIX9V2JP
CitalopramCITALOPRAM HYDROBROMIDEQUALLENT PHARMACEUTICALS HEALTH LLCe0822069-9672-4d4c-bc1a-8739b0dd045c2024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEExelencia importers0d6d4098-4121-477e-b404-3ab18628ed682024-06-30WarningsExact identifier
unii: 15FIX9V2JP
Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc28c51c59-dbfb-45e5-b536-6e5d5c5560d62024-06-28WarningsExact identifier
unii: 15FIX9V2JP
LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incf6457973-3718-44cd-a764-de0b089d4eee2024-06-28WarningsExact identifier
unii: 15FIX9V2JP
LOreal Paris Visible Lift Serum Absolute Advanced Makeup Broad Spectrum SPF 17 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc8598d56b-adcd-48e8-b6fc-77bc934009c72024-06-27WarningsExact identifier
unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incbe2a83fb-e4f8-4313-b5bd-150f351fb3452024-06-26WarningsExact identifier
unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE066a0951-2e7e-40c0-8035-4d708a32f16c2024-06-26WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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