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 106 of 106 · 2,119 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SkinPerfect Primer SPF 30TITANIUM DIOXIDE AND ZINC OXIDEDermalogica, Inc.5fc75cef-5b76-44ab-891a-7b90c04a06812017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 TaupeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc46e1dc9c-acb8-4a61-8503-065d18c9eb302017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 CreamZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc5096ab46-879c-49ec-b0f0-18462814adec2017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 Warm BeigeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incd8cab2e9-02fd-451c-b0e0-70ba0fc274d52017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 SandZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Ince5e8d83e-b3e6-470f-b521-4d7e96ecd1b62017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 BeigeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incec6749b7-377b-4ac5-8992-ac709bd0204e2017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Age Renewal Firming and Hydrating Moisturizer SPF 30OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDECVS Health5f6f677d-2404-4e56-a48f-4263314afd9b2017-03-14WarningsExact identifier
unii: 15FIX9V2JP
Your Name Cosmetics Brightening CC Cream Broad Spectrum SPF 20YOUR NAME COSMETICS BRIGHTENING CC CREAM BROAD SPECTRUM SPF 20Mana Productsae6a86d2-a95b-4fa8-9676-233ef9fdc3b02017-02-22WarningsExact identifier
unii: 15FIX9V2JP
Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 SunscreenNUANCE SALMA HAYEK RENEWED RADIANCE BRIGHTENING BB CREAM BROAD SPECTRUM SPF 30 SUNSCREENCVS Pharmacy, Inc7795e651-838e-41f8-b48d-bd2e0dd1beec2017-01-18WarningsExact identifier
unii: 15FIX9V2JP
DERMAdoctor DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30DERMADOCTOR DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30Mana Productscec89a7e-1670-4d3c-b48c-28ed1ea7f9572016-12-07WarningsExact identifier
unii: 15FIX9V2JP
Age Renewal FirmingOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAMCOL Health & Beauty Solutions, Inc. DBA6cb27f87-40a3-4049-aded-eb788509c5752016-10-07WarningsExact identifier
unii: 15FIX9V2JP
Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 SunscreenNUANCE SALMA HAYEK RENEWED RADIANCE BRIGHTENING BB CREAM BROAD SPECTRUM SPF 30 SUNSCREENMana Productsd0e00d97-dbf4-46af-aeda-bdfd6f49b5ab2016-09-08WarningsExact identifier
unii: 15FIX9V2JP
Meijer Kids Tear Free SPF 50TITANIUM DIOXIDE, ZINC OXIDEMeijer Distribution, Inc.7415511e-1ecf-4646-b64b-267fbf7d116b2016-06-02WarningsExact identifier
unii: 15FIX9V2JP
Meijer Baby Tear Free SPF 50TITANIUM DIOXIDE, ZINC OXIDEMeijer Distributing Inc.2434de23-bcc9-4a83-9945-16fc3f2b8c612016-06-01WarningsExact identifier
unii: 15FIX9V2JP
TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted)OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.6a996e03-907f-4e6a-b232-0892b86956b02015-08-21WarningsExact identifier
unii: 15FIX9V2JP
Renewal Firming Day Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEBURT'S BEES, INC.18ceb5d8-4b76-6a54-e054-00144ff88e882015-06-18WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD.30468afc-9616-4765-b046-12e97a0a78272010-12-20WarningsExact identifier
unii: 15FIX9V2JP
b808f809-40fa-43c6-a33f-2ec21a293051b808f809-40fa-43c6-a33f-2ec21a2930512010-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: b808f809-40fa-43c6-a33f-2ec21a293051
spl set id: b808f809-40fa-43c6-a33f-2ec21a293051
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.