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 3 of 5 · 88 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CitalopramCITALOPRAM HYDROBROMIDEBryant Ranch Prepack0bc0e09e-0f1d-4d52-b8fe-3ef8a2e5ea522025-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077031
rxcui: 200371
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEATLANTIC BIOLOGICALS CORP.2640311d-8b88-4513-9c80-a08390b8142a2025-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.c577b306-ee7c-8364-e053-2a95a90abb132025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
unii: I1E9D14F36
CITALOPRAMCITALOPRAMGolden State Medical Supply, Inc.f3a26d92-b662-4896-82eb-2619480424082025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMPD-Rx Pharmaceuticals, Inc.75f6db65-e4ed-470a-9e56-12791f22ee9b2025-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.c584909b-e7b2-7108-e053-2995a90a2f542024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAMAdvanced Rx of Tennessee, LLCb3541f26-dc8d-6591-e053-2995a90a23d92024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEAdvanced Rx Pharmacy of Tennessee, LLCf8b06b55-f6a2-2438-e053-6394a90a530a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077031
ndc (package): 80425-0309-2
ndc (package): 80425-0309-1
ndc (package): 80425-0309-3
ndc (product): 80425-0309
ndc11 (package): 80425030901
rxcui: 283672
spl id: 2a9bf621-afbd-7627-e063-6294a90a77a9
spl set id: f8b06b55-f6a2-2438-e053-6394a90a530a
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEQuality Care Products, LLC6fc110ba-87e7-404e-9e00-b680f354c7b02024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEQuality Care Products, LLCe22fe468-5d9e-4ec7-a69b-4988e0b8acbd2024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEBryant Ranch Prepack8719bd44-36b6-468d-9203-8c53a26451842024-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEProficient Rx LP1a136cc3-d655-4f3c-8710-2603dc0084922024-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutions2500cc9d-a67d-46c5-9a76-99bc63959d672024-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077031
rxcui: 283672
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEBryant Ranch Prepack15cb00da-4435-4930-90d0-faadf2739a5c2024-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMBryant Ranch Prepack2a8acad8-0ba0-4631-9f6d-f587e7a8558c2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMAmneal Pharmaceuticals LLC6a402640-1c9d-4fca-8b5b-e1ac1dd4ca5a2024-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEA-S Medication Solutions05421bee-f746-418e-bb9c-ab44a89b567d2024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
CITALOPRAMCITALOPRAMEpic Pharma, LLC08b6d5da-5919-4760-9e16-3b478a14d6d72024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDEA-S Medication Solutionsb244d4eb-8311-4663-8bca-dc08e88e5f5d2024-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077031
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMCipla USA Inc.0580559a-783a-4a0a-8d81-ee30a29077c52024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36

Reported adverse events (FAERS/openFDA)#

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