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 1 of 5 · 89 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CitalopramCITALOPRAM HYDROBROMIDEREMEDYREPACK INC.0109f365-bebd-4810-a56f-4451e10245db2026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077031
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDEREMEDYREPACK INC.625a78b2-4751-4ca5-91b6-7c85fd9f8c2e2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077031
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAMREMEDYREPACK INC.f79f878e-99fb-4757-8abb-931af1fa9e2b2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
unii: I1E9D14F36
CitalopramCITALOPRAMREMEDYREPACK INC.aa9c1440-354f-43a6-9e70-fd7bafcb03c52026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMREMEDYREPACK INC.c9809dfe-939e-4f9d-b6dd-f9808fd9f2b12026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMREMEDYREPACK INC.25b0d184-2a4c-42b0-9a57-7a00fa3e0cd72026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAMPD-Rx Pharmaceuticals, Inc.9fe40d83-8945-4577-add5-28d52410154e2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMSt. Mary's Medical Park Pharmacydb900453-4777-4142-a236-5d3a6152d0a52026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAMCoupler LLC53e5d66f-7902-76ac-e063-6294a90aa5262026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
unii: I1E9D14F36
CitalopramCITALOPRAMCoupler LLC53e6d0a4-95d9-9c1a-e063-6294a90a9d182026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMBryant Ranch Prepack9b53c14c-224c-49ed-8a00-96f871593ab02026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
unii: I1E9D14F36
CitalopramCITALOPRAMASCLEMED USA INC.df8db06a-ced7-4dd6-83bd-c61d2f68f1b12026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMSt. Mary's Medical Park Pharmacy351ca54b-0eb6-4e93-8ab4-82fb18dcc9e12026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
unii: I1E9D14F36
CitalopramCITALOPRAMQPharma, Inc.f35bfd9e-afb6-409d-a804-6073d812609d2026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAMPD-Rx Pharmaceuticals, Inc.43785b49-5d1e-4ae9-b2ff-26be910bde7f2026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAMREMEDYREPACK INC.a26772e7-6e4d-489b-bb5e-5bc322ef6dfe2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
unii: I1E9D14F36
CitalopramCITALOPRAMPD-Rx Pharmaceuticals, Inc.df929b3f-0cda-4a75-96d3-22e6b0edbbc92026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
unii: I1E9D14F36
CitalopramCITALOPRAMREMEDYREPACK INC.bdc0c228-797a-42dd-8114-aa68c1eb33002026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAMCoupler LLC50380ce5-c77f-3ee3-e063-6394a90a17ae2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAMCardinal Health 107, LLC6c8942f8-963a-4007-a147-b77ac629e4d42026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
unii: I1E9D14F36

Reported adverse events (FAERS/openFDA)#

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