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 89 of 106 · 2,119 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATOMY DERMA CALMING SUNTITANIUM DIOXIDEATOMY CO., LTD.fd5fc3ba-6e7c-4e48-8e65-47c03141df452024-01-30WarningsExact identifier
unii: 15FIX9V2JP
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
GENTEAL TEARSDEXTRAN 70, GLYCERIN, HYPROMELLOSEA-S Medication Solutionsa2b715e9-332d-4f0b-b8e5-ebc0006815862024-01-21WarningsExact identifier
unii: 3NXW29V3WO
Shunly Radiant Translucent SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC20783833-ee7f-4425-b4ab-ab61cda5b2c82024-01-17WarningsExact identifier
unii: 15FIX9V2JP
Shunly Radiant Translucent Tinted SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC1aeb5e05-730c-4c5c-b164-ad9347b0cd932024-01-17WarningsExact identifier
unii: 15FIX9V2JP
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc4a243c9f-ca88-47fb-8777-1da79c001c732024-01-16WarningsExact identifier
unii: 15FIX9V2JP
MY MEDIC SPF 30 REEF FRIENDLY SUNSCREENHOMOSALATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE, PHENYLBENZIMIDAZOLE SULFONIC ACIDSled Distribution, LLCec252876-7205-83ec-e053-2a95a90a14632024-01-15WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDECosmetique Active Productionfd2541e1-c409-40a8-9e3f-6ff69084ea662024-01-15WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Incbc72048a-4786-44c2-97ce-0220822816542024-01-15WarningsExact identifier
unii: 15FIX9V2JP
Revlon Colorstay Light Cover FoundationHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE,ZINC OXIDERevlonb0006b5f-0d56-0efb-e053-2a95a90a59792024-01-12WarningsExact identifier
unii: 15FIX9V2JP
PREVAGE CITY SMARTTITANIUM DIOXIDE, ZINC OXIDEREVLONb60c9b41-cf32-ee94-e053-2a95a90abab02024-01-12WarningsExact identifier
unii: 15FIX9V2JP
CERAMIDE MAKEUP SPF 15OCTINOXATE, TITANIUM DIOXIDEREVLONb3ad9686-47ed-4b60-e053-2995a90abcdd2024-01-12WarningsExact identifier
unii: 15FIX9V2JP
I Conceal Flawless Foundation BS SPF 30 Sunscreen SUEDEZINC OXIDE AND TITANIUM DIOXIDEAllure Labs0e9d006c-2ea0-8228-e063-6394a90a65d62024-01-10WarningsExact identifier
unii: 15FIX9V2JP
EVEN BETTER MAKEUP BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCd4de3c7b-3993-40e5-88a4-f6005ab975312024-01-09WarningsExact identifier
unii: 15FIX9V2JP
Principal Secret Reclaim Oil Control hydrator SPF-8TITANIUM DIOXIDEGuthy-Renker LLC97b7cd4e-78aa-418b-a112-263971fa98272024-01-08WarningsExact identifier
unii: 15FIX9V2JP
Prime Time Daily Protecting Primer SPF 30SPF 30 PRIME TIME PRIMERAutumn Harp Inc.f2619092-3e7f-5105-e053-2a95a90a3f5a2024-01-03WarningsExact identifier
unii: 15FIX9V2JP
ARTISTRY IDEAL RADIANCE UV Protect SPF 50 PLUS Broad Spectrum SunscreenOCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDEAmway Corpa1a700b5-d039-4bd2-8420-5c20530957062024-01-02WarningsExact identifier
unii: 15FIX9V2JP
CitalopramCITALOPRAMNuCare Pharmaceuticals,Inc.0dfb11d9-f48d-56ee-e063-6294a90ad2562024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
Josie Maran Argan Daily Moisturizer SPF47 Protect and PerfectZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.cb91c130-45d4-46a0-9628-50e701a6960c2024-01-02Boxed warning, WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay New 50 Body and Face SPF 50 Mineral Anthelios Gentle 100 percent mineral UV filters Soft finish with Cell Ox ShieldTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incc0f7ae46-7161-4d48-9386-007bfafecfd52024-01-01WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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