FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
12634-629
11-digit product format
126340629
Labeler code
12634
Product ID
12634-629_357d9c23-a8fc-3b21-e054-00144ff88e88
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
10 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
12634-629-002021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-012021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-092021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-402021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-422021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-502021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-522021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-542021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-572021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-592021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-602021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-612021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-632021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-662021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-672021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-692021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-712021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-742021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-782021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-792021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-802021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-812021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-822021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-852021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-912021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-942021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-952021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP
12634-629-962021-01-29C16284748780-1ba0f9c33-2c01-a910-e053-dadaa90a0b85Citalopram Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-629-00Citalopram Hydrobromide10 in 1 BOTTLETABLET103
12634-629-01Citalopram Hydrobromide100 in 1 BOTTLETABLET1003
12634-629-09Citalopram Hydrobromide35 in 1 BOTTLETABLET353
12634-629-40Citalopram Hydrobromide40 in 1 BOTTLETABLET403
12634-629-42Citalopram Hydrobromide42 in 1 BOTTLETABLET423
12634-629-50Citalopram Hydrobromide50 in 1 BOTTLETABLET503
12634-629-52Citalopram Hydrobromide12 in 1 BLISTER PACKTABLET123
12634-629-54Citalopram Hydrobromide14 in 1 BLISTER PACKTABLET143
12634-629-57Citalopram Hydrobromide20 in 1 BLISTER PACKTABLET203
12634-629-59Citalopram Hydrobromide30 in 1 BLISTER PACKTABLET303
12634-629-60Citalopram Hydrobromide60 in 1 BOTTLETABLET603
12634-629-61Citalopram Hydrobromide10 in 1 BLISTER PACKTABLET103
12634-629-63Citalopram Hydrobromide3 in 1 BLISTER PACKTABLET33
12634-629-66Citalopram Hydrobromide6 in 1 BLISTER PACKTABLET63
12634-629-67Citalopram Hydrobromide7 in 1 BLISTER PACKTABLET73
12634-629-69Citalopram Hydrobromide9 in 1 BLISTER PACKTABLET93
12634-629-71Citalopram Hydrobromide30 in 1 BOTTLETABLET303
12634-629-74Citalopram Hydrobromide24 in 1 BOTTLETABLET243
12634-629-78Citalopram Hydrobromide28 in 1 BOTTLETABLET283
12634-629-79Citalopram Hydrobromide25 in 1 BOTTLETABLET253
12634-629-80Citalopram Hydrobromide20 in 1 BOTTLETABLET203
12634-629-81Citalopram Hydrobromide21 in 1 BOTTLETABLET213
12634-629-82Citalopram Hydrobromide12 in 1 BOTTLETABLET123
12634-629-85Citalopram Hydrobromide15 in 1 BOTTLETABLET153
12634-629-91Citalopram Hydrobromide1 in 1 BLISTER PACKTABLET13
12634-629-94Citalopram Hydrobromide4 in 1 BOTTLETABLET43
12634-629-95Citalopram Hydrobromide5 in 1 BOTTLETABLET53
12634-629-96Citalopram Hydrobromide6 in 1 BOTTLETABLET63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-629CITALOPRAM HYDROBROMIDE TABLET [APOTHECA INC.]3Legacy NDC, 28 package rows20160618_3568b0ca-ba12-310b-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN3568b0ca-ba12-310b-e054-00144ff8d46c3
283672citalopram 10 MG Oral TabletSCD3568b0ca-ba12-310b-e054-00144ff8d46c3
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY3568b0ca-ba12-310b-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-629-001263406290010 in 1 BOTTLEHistorical
12634-629-0112634062901100 in 1 BOTTLEHistorical
12634-629-091263406290935 in 1 BOTTLEHistorical
12634-629-401263406294040 in 1 BOTTLEHistorical
12634-629-421263406294242 in 1 BOTTLEHistorical
12634-629-501263406295050 in 1 BOTTLEHistorical
12634-629-521263406295212 in 1 BLISTER PACKHistorical
12634-629-541263406295414 in 1 BLISTER PACKHistorical
12634-629-571263406295720 in 1 BLISTER PACKHistorical
12634-629-591263406295930 in 1 BLISTER PACKHistorical
12634-629-601263406296060 in 1 BOTTLEHistorical
12634-629-611263406296110 in 1 BLISTER PACKHistorical
12634-629-63126340629633 in 1 BLISTER PACKHistorical
12634-629-66126340629666 in 1 BLISTER PACKHistorical
12634-629-67126340629677 in 1 BLISTER PACKHistorical
12634-629-69126340629699 in 1 BLISTER PACKHistorical
12634-629-711263406297130 in 1 BOTTLEHistorical
12634-629-741263406297424 in 1 BOTTLEHistorical
12634-629-781263406297828 in 1 BOTTLEHistorical
12634-629-791263406297925 in 1 BOTTLEHistorical
12634-629-801263406298020 in 1 BOTTLEHistorical
12634-629-811263406298121 in 1 BOTTLEHistorical
12634-629-821263406298212 in 1 BOTTLEHistorical
12634-629-851263406298515 in 1 BOTTLEHistorical
12634-629-91126340629911 in 1 BLISTER PACKHistorical
12634-629-94126340629944 in 1 BOTTLEHistorical
12634-629-95126340629955 in 1 BOTTLEHistorical
12634-629-96126340629966 in 1 BOTTLEHistorical