FDA.reportPublic FDA data

NDC 76282-208-01 - 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
76282-208
Requested NDC
76282-208-01
Package NDCs from labels
76282-208-30, 76282-208-90, 76282-208-05, 76282-208-10, 76282-208-01
Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Effective date
2026-03-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CITALOPRAM HYDROBROMIDE - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2026-03-04HUMAN PRESCRIPTION DRUG LABEL
CITALOPRAM - Exelan Pharmaceuticals Inc. | InvaGen Pharmaceuticals Inc.Exelan Pharmaceuticals Inc. | InvaGen Pharmaceuticals Inc.2024-08-01HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-208-05CITALOPRAM HYDROBROMIDE500 in 1 BOTTLETABLET50015
76282-208-10CITALOPRAM HYDROBROMIDE1000 in 1 BOTTLETABLET100015
76282-208-30CITALOPRAM HYDROBROMIDE30 in 1 BOTTLETABLET3015
76282-208-90CITALOPRAM HYDROBROMIDE90 in 1 BOTTLETABLET9015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-208CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 4 package rows20240912_a8e8fde2-8392-4d5b-902b-e2b9dd55a02d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-208-01EA - Each76282-2082f395c5a-7bf1-4b00-9b6d-09bb7957a7c712013-02-13
76282-208-05EA - Each76282-2089bd5dca2-1b6b-4070-9fe8-be1eb7aec31c12013-02-13
76282-208-10EA - Each76282-208c7681eb7-5aa6-4582-9cfd-fc7b0c18609812013-02-13
76282-208-30EA - Each76282-20868c2e058-4593-4b8a-afca-6e766e300dcc12013-02-13
76282-208-90EA - Each76282-208be2d5169-e537-4b61-bcbd-ebf40beac75212017-09-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]2
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]2
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BCITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]2

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 91 of 113 · 2,248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs LLC18e1edd9-e39b-c91f-e063-6394a90a32a02024-05-20WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs, LLC18e4c50d-eb91-c269-e063-6394a90a79992024-05-20WarningsExact identifier
unii: 15FIX9V2JP
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEAllure Labs18aa2604-c8f0-ca04-e063-6294a90a1c252024-05-17WarningsExact identifier
unii: 15FIX9V2JP
CitalopramCITALOPRAM HYDROBROMIDEAurobindo Pharma Limited2632b547-2e13-447f-ac85-c774e437d6a82024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
Jack BlackTITANIUM DIOXIDE, ZINC OXIDEJack Black L.L.C181d5bf3-ce91-cb2c-e063-6294a90a51c42024-05-10WarningsExact identifier
unii: 15FIX9V2JP
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs181e3f34-c5b2-0976-e063-6394a90a9a782024-05-10WarningsExact identifier
unii: 15FIX9V2JP
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs180b2939-5ae4-88fb-e063-6394a90aad932024-05-09WarningsExact identifier
unii: 15FIX9V2JP
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEAurobindo Pharma Limitede7a2cbdd-1bdb-4e59-a3dd-298a189753ae2024-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I1E9D14F36
CitalopramCITALOPRAMA-S Medication Solutionsc91684c7-fddb-4cf0-9711-b0484c8c7e8b2024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077534
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAMA-S Medication Solutions17af7a8d-ef57-4253-96ed-e457e0062eb52024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077534
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMA-S Medication Solutions04ac5286-fc2e-4990-a574-ea21131ef7312024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077534
rxcui: 283672
unii: I1E9D14F36
Natural Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESarati International, Inc.16ef922d-78d1-1e70-e063-6394a90a3bbf2024-04-25WarningsExact identifier
unii: 15FIX9V2JP
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsfc766b76-18c1-42cd-b276-f720f5821c112024-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 AlabasterTITANIUM DIOXIDEChantecaille Beaute Ince1c562b8-76c0-4c6e-9276-900784c8639e2024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 WheatTITANIUM DIOXIDEChantecaille Beaute Inc89f19f7a-60e3-4080-a49a-a4eb3e6c27de2024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 AuraTITANIUM DIOXIDEChantecaille Beaute Incde441a6c-55e3-4b11-afb3-d7db3c6971f02024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 BlissTITANIUM DIOXIDEChantecaille Beaute Inc16d9e226-7694-922a-e063-6394a90aea852024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 GlowTITANIUM DIOXIDEChantecaille Beaute Incf868fe4f-4c10-4f0f-9f1d-008f067744082024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 NudeTITANIUM DIOXIDEChantecaille Beaute Inccb8feddc-ae98-42ea-ad1e-583dcacfa5d92024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 OpalineTITANIUM DIOXIDEChantecaille Beaute Inc1c918b4b-763b-48bf-9ae3-661eabafee162024-04-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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