FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
12634-027
11-digit product format
126340027
Labeler code
12634
Product ID
12634-027_3683a7d1-b1d7-3b08-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
40 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
12634-027-002021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-012021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-092021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-402021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-422021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-502021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-522021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-542021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-572021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-592021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-602021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-612021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-632021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-662021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-672021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-692021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-712021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-742021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-782021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-792021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-802021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-812021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-822021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-852021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-912021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-942021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-952021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-027-962021-01-29C16284748780-1ba0f9c33-4077-a910-e053-dadaa90a0b85Citalopram Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-027-00Citalopram Hydrobromide10 in 1 BOTTLETABLET104
12634-027-01Citalopram Hydrobromide100 in 1 BOTTLETABLET1004
12634-027-09Citalopram Hydrobromide35 in 1 BOTTLETABLET354
12634-027-40Citalopram Hydrobromide40 in 1 BOTTLETABLET404
12634-027-42Citalopram Hydrobromide42 in 1 BOTTLETABLET424
12634-027-50Citalopram Hydrobromide50 in 1 BOTTLETABLET504
12634-027-52Citalopram Hydrobromide12 in 1 BLISTER PACKTABLET124
12634-027-54Citalopram Hydrobromide14 in 1 BLISTER PACKTABLET144
12634-027-57Citalopram Hydrobromide20 in 1 BLISTER PACKTABLET204
12634-027-59Citalopram Hydrobromide30 in 1 BLISTER PACKTABLET304
12634-027-60Citalopram Hydrobromide60 in 1 BOTTLETABLET604
12634-027-61Citalopram Hydrobromide10 in 1 BLISTER PACKTABLET104
12634-027-63Citalopram Hydrobromide3 in 1 BLISTER PACKTABLET34
12634-027-66Citalopram Hydrobromide6 in 1 BLISTER PACKTABLET64
12634-027-67Citalopram Hydrobromide7 in 1 BLISTER PACKTABLET74
12634-027-69Citalopram Hydrobromide9 in 1 BLISTER PACKTABLET94
12634-027-71Citalopram Hydrobromide30 in 1 BOTTLETABLET304
12634-027-74Citalopram Hydrobromide24 in 1 BOTTLETABLET244
12634-027-78Citalopram Hydrobromide28 in 1 BOTTLETABLET284
12634-027-79Citalopram Hydrobromide25 in 1 BOTTLETABLET254
12634-027-80Citalopram Hydrobromide20 in 1 BOTTLETABLET204
12634-027-81Citalopram Hydrobromide21 in 1 BOTTLETABLET214
12634-027-82Citalopram Hydrobromide12 in 1 BOTTLETABLET124
12634-027-85Citalopram Hydrobromide15 in 1 BOTTLETABLET154
12634-027-91Citalopram Hydrobromide1 in 1 BLISTER PACKTABLET14
12634-027-94Citalopram Hydrobromide4 in 1 BOTTLETABLET44
12634-027-95Citalopram Hydrobromide5 in 1 BOTTLETABLET54
12634-027-96Citalopram Hydrobromide6 in 1 BOTTLETABLET64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-027CITALOPRAM HYDROBROMIDE TABLET [APOTHECA INC.]4Legacy NDC, 28 package rows20160630_356f48c3-3b0e-65b5-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSN356f48c3-3b0e-65b5-e054-00144ff8d46c4
309314citalopram 40 MG Oral TabletSCD356f48c3-3b0e-65b5-e054-00144ff8d46c4
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY356f48c3-3b0e-65b5-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-027-001263400270010 in 1 BOTTLEHistorical
12634-027-0112634002701100 in 1 BOTTLEHistorical
12634-027-091263400270935 in 1 BOTTLEHistorical
12634-027-401263400274040 in 1 BOTTLEHistorical
12634-027-421263400274242 in 1 BOTTLEHistorical
12634-027-501263400275050 in 1 BOTTLEHistorical
12634-027-521263400275212 in 1 BLISTER PACKHistorical
12634-027-541263400275414 in 1 BLISTER PACKHistorical
12634-027-571263400275720 in 1 BLISTER PACKHistorical
12634-027-591263400275930 in 1 BLISTER PACKHistorical
12634-027-601263400276060 in 1 BOTTLEHistorical
12634-027-611263400276110 in 1 BLISTER PACKHistorical
12634-027-63126340027633 in 1 BLISTER PACKHistorical
12634-027-66126340027666 in 1 BLISTER PACKHistorical
12634-027-67126340027677 in 1 BLISTER PACKHistorical
12634-027-69126340027699 in 1 BLISTER PACKHistorical
12634-027-711263400277130 in 1 BOTTLEHistorical
12634-027-741263400277424 in 1 BOTTLEHistorical
12634-027-781263400277828 in 1 BOTTLEHistorical
12634-027-791263400277925 in 1 BOTTLEHistorical
12634-027-801263400278020 in 1 BOTTLEHistorical
12634-027-811263400278121 in 1 BOTTLEHistorical
12634-027-821263400278212 in 1 BOTTLEHistorical
12634-027-851263400278515 in 1 BOTTLEHistorical
12634-027-91126340027911 in 1 BLISTER PACKHistorical
12634-027-94126340027944 in 1 BOTTLEHistorical
12634-027-95126340027955 in 1 BOTTLEHistorical
12634-027-96126340027966 in 1 BOTTLEHistorical