FDA.reportPublic FDA data

NDC 80425-0309-01 - 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
80425-0309
Requested NDC
80425-0309-01
Package NDCs from labels
80425-0309-1, 80425-0309-2, 80425-0309-3, 80425-0309-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Citalopram Hydrobromide - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0309-1Citalopram Hydrobromide30 in 1 BOTTLETABLET, FILM COATED302
80425-0309-2Citalopram Hydrobromide60 in 1 BOTTLETABLET, FILM COATED602
80425-0309-3Citalopram Hydrobromide90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0309CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f8b06b55-f6a2-2438-e053-6394a90a530a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0309-1EA - Each80425-03096ec07d67-c966-4ba5-a8c3-3b925ee4e5ea12023-06-06
80425-0309-2EA - Each80425-0309fa330332-8c81-4367-9abb-c24055f2bfa212023-06-06
80425-0309-3EA - Each80425-030955a0606c-0fc1-4907-8202-28167c1823da12023-06-06

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 4 of 5 · 88 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
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals, Inc.4f45c818-b324-6ca6-e054-00144ff8d46c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.579836d8-64ed-de2d-e053-2a91aa0a83922024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.549a5b3f-4928-1ae5-e054-00144ff8d46c2024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDEQUALLENT PHARMACEUTICALS HEALTH LLCe0822069-9672-4d4c-bc1a-8739b0dd045c2024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077031
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMMylan Pharmaceuticals Inc.825c0c49-5fbf-6d8b-cb8c-94ebf0eda0432024-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.9987a273-e6d7-54cd-e053-2a95a90a0aaa2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDEAurobindo Pharma Limited2632b547-2e13-447f-ac85-c774e437d6a82024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077031
ndc (product): 65862-005
rxcui: 283672
rxcui: 200371
rxcui: 309314
spl id: 5642ea11-17b4-431a-a896-2cb336929100
spl set id: 2632b547-2e13-447f-ac85-c774e437d6a8
unii: I1E9D14F36
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
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAMA-S Medication Solutions17af7a8d-ef57-4253-96ed-e457e0062eb52024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMA-S Medication Solutions04ac5286-fc2e-4990-a574-ea21131ef7312024-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsfc766b76-18c1-42cd-b276-f720f5821c112024-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077031
rxcui: 200371
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDECamber Pharmaceuticals, Inc.dc7b3f88-ee55-4e3e-9ed4-fc06aa7620cc2024-02-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsc6730edc-7226-4521-a04a-1bf296b01b8d2024-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077031
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMNuCare Pharmaceuticals,Inc.0dfb11d9-f48d-56ee-e063-6294a90ad2562024-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEA-S Medication Solutions9059c8f1-8755-492d-aba2-5f5088ce69d32023-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEA-S Medication Solutions9d2f8f9f-9710-48e0-bc18-105a2af1073b2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
CelexaCITALOPRAMAllergan, Inc.4259d9b1-de34-43a4-85a8-41dd214e91772023-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDENCS HealthCare of KY, LLC dba Vangard Labsfd761647-e16b-45b3-a4bc-364de0ed70152023-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077031
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36

Reported adverse events (FAERS/openFDA)#

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