FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
12634-023
11-digit product format
126340023
Labeler code
12634
Product ID
12634-023_357dc373-4314-1e36-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA078216
Marketing category
ANDA
Marketing start
2007-10-18
Marketing end
0000-00-00
Substance
CITALOPRAM HYDROBROMIDE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
475812f9-1b2c-4cb0-9e72-1e52f935ae6fProduct name120221114
0b05d650-9b7b-4b36-a6f4-1a850d5a2e64Product name120151228
e61ea6cb-0b08-40a9-a984-7b23201c7aa2Product name120151222

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12634-023-002021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-012021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-092021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-402021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-422021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-502021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-522021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-542021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-572021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-592021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-602021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-612021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-632021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-662021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-672021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-692021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-712021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-742021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-782021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-792021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-802021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-812021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-822021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-852021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-912021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-942021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-952021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-023-962021-01-29C16284748780-1ba0f9c33-17de-a910-e053-dadaa90a0b85Citalopram Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-023-00Citalopram Hydrobromide10 in 1 BOTTLETABLET102
12634-023-01Citalopram Hydrobromide100 in 1 BOTTLETABLET1002
12634-023-09Citalopram Hydrobromide35 in 1 BOTTLETABLET352
12634-023-40Citalopram Hydrobromide40 in 1 BOTTLETABLET402
12634-023-42Citalopram Hydrobromide42 in 1 BOTTLETABLET422
12634-023-50Citalopram Hydrobromide50 in 1 BOTTLETABLET502
12634-023-52Citalopram Hydrobromide12 in 1 BLISTER PACKTABLET122
12634-023-54Citalopram Hydrobromide14 in 1 BLISTER PACKTABLET142
12634-023-57Citalopram Hydrobromide20 in 1 BLISTER PACKTABLET202
12634-023-59Citalopram Hydrobromide30 in 1 BLISTER PACKTABLET302
12634-023-60Citalopram Hydrobromide60 in 1 BOTTLETABLET602
12634-023-61Citalopram Hydrobromide10 in 1 BLISTER PACKTABLET102
12634-023-63Citalopram Hydrobromide3 in 1 BLISTER PACKTABLET32
12634-023-66Citalopram Hydrobromide6 in 1 BLISTER PACKTABLET62
12634-023-67Citalopram Hydrobromide7 in 1 BLISTER PACKTABLET72
12634-023-69Citalopram Hydrobromide9 in 1 BLISTER PACKTABLET92
12634-023-71Citalopram Hydrobromide30 in 1 BOTTLETABLET302
12634-023-74Citalopram Hydrobromide24 in 1 BOTTLETABLET242
12634-023-78Citalopram Hydrobromide28 in 1 BOTTLETABLET282
12634-023-79Citalopram Hydrobromide25 in 1 BOTTLETABLET252
12634-023-80Citalopram Hydrobromide20 in 1 BOTTLETABLET202
12634-023-81Citalopram Hydrobromide21 in 1 BOTTLETABLET212
12634-023-82Citalopram Hydrobromide12 in 1 BOTTLETABLET122
12634-023-85Citalopram Hydrobromide15 in 1 BOTTLETABLET152
12634-023-91Citalopram Hydrobromide1 in 1 BLISTER PACKTABLET12
12634-023-94Citalopram Hydrobromide4 in 1 BOTTLETABLET42
12634-023-95Citalopram Hydrobromide5 in 1 BOTTLETABLET52
12634-023-96Citalopram Hydrobromide6 in 1 BOTTLETABLET62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-023CITALOPRAM HYDROBROMIDE TABLET [APOTHECA INC.]2Legacy NDC, 28 package rows20160618_356a907d-8aa4-1121-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSN356a907d-8aa4-1121-e054-00144ff8d46c2
200371citalopram 20 MG Oral TabletSCD356a907d-8aa4-1121-e054-00144ff8d46c2
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY356a907d-8aa4-1121-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-023-001263400230010 in 1 BOTTLEHistorical
12634-023-0112634002301100 in 1 BOTTLEHistorical
12634-023-091263400230935 in 1 BOTTLEHistorical
12634-023-401263400234040 in 1 BOTTLEHistorical
12634-023-421263400234242 in 1 BOTTLEHistorical
12634-023-501263400235050 in 1 BOTTLEHistorical
12634-023-521263400235212 in 1 BLISTER PACKHistorical
12634-023-541263400235414 in 1 BLISTER PACKHistorical
12634-023-571263400235720 in 1 BLISTER PACKHistorical
12634-023-591263400235930 in 1 BLISTER PACKHistorical
12634-023-601263400236060 in 1 BOTTLEHistorical
12634-023-611263400236110 in 1 BLISTER PACKHistorical
12634-023-63126340023633 in 1 BLISTER PACKHistorical
12634-023-66126340023666 in 1 BLISTER PACKHistorical
12634-023-67126340023677 in 1 BLISTER PACKHistorical
12634-023-69126340023699 in 1 BLISTER PACKHistorical
12634-023-711263400237130 in 1 BOTTLEHistorical
12634-023-741263400237424 in 1 BOTTLEHistorical
12634-023-781263400237828 in 1 BOTTLEHistorical
12634-023-791263400237925 in 1 BOTTLEHistorical
12634-023-801263400238020 in 1 BOTTLEHistorical
12634-023-811263400238121 in 1 BOTTLEHistorical
12634-023-821263400238212 in 1 BOTTLEHistorical
12634-023-851263400238515 in 1 BOTTLEHistorical
12634-023-91126340023911 in 1 BLISTER PACKHistorical
12634-023-94126340023944 in 1 BOTTLEHistorical
12634-023-95126340023955 in 1 BOTTLEHistorical
12634-023-96126340023966 in 1 BOTTLEHistorical