FDA.reportPublic FDA data

CITALOPRAM HYDROBROMIDE

Product NDC
43353-112
11-digit product format
433530112
Labeler code
43353
Product ID
43353-112_4c38f808-9a23-b5b5-e063-6394a90ae44b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CITALOPRAM
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077534
Marketing category
ANDA
Marketing start
2012-10-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CITALOPRAM HYDROBROMIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui200371, 309314

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-112-15CITALOPRAM HYDROBROMIDE15 in 1 BOTTLETABLET156
43353-112-30CITALOPRAM HYDROBROMIDE30 in 1 BOTTLETABLET306
43353-112-45CITALOPRAM HYDROBROMIDE45 in 1 BOTTLETABLET456
43353-112-53CITALOPRAM HYDROBROMIDE60 in 1 BOTTLETABLET606
43353-112-60CITALOPRAM HYDROBROMIDE90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-112-15EA - Each43353-11215aa6fb7-1003-4f36-914d-be027c6e3a0912016-07-19
43353-112-30EA - Each43353-1121b844d39-85fa-464f-93b1-5e7cb8f391f012026-03-17
43353-112-45EA - Each43353-112ff7bd251-3205-4dd8-9343-67943a7c394212016-07-19
43353-112-53EA - Each43353-112222bb355-6a22-4d0a-bf6b-9b05cdfd7a2f12016-07-19
43353-112-60EA - Each43353-112853e37cf-92b3-430e-a172-f86475783df612016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-112CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 5 package rows20171026_7307df53-d570-4e26-971d-e97522ccce7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSN7307df53-d570-4e26-971d-e97522ccce7f6
309314citalopram 40 MG Oral TabletPSN7307df53-d570-4e26-971d-e97522ccce7f6
200371citalopram 20 MG Oral TabletSCD7307df53-d570-4e26-971d-e97522ccce7f6
309314citalopram 40 MG Oral TabletSCD7307df53-d570-4e26-971d-e97522ccce7f6
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY7307df53-d570-4e26-971d-e97522ccce7f6
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY7307df53-d570-4e26-971d-e97522ccce7f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-112-154335301121515 TABLET in 1 BOTTLE (43353-112-15) 15 tablet2015-10-090000-00-00NoNoCurrent
43353-112-304335301123030 TABLET in 1 BOTTLE (43353-112-30) 30 tablet2015-10-09NoNoHistorical
43353-112-454335301124545 TABLET in 1 BOTTLE (43353-112-45) 45 tablet2015-10-090000-00-00NoNoCurrent
43353-112-534335301125360 TABLET in 1 BOTTLE (43353-112-53) 60 tablet2015-10-090000-00-00NoNoCurrent
43353-112-604335301126090 TABLET in 1 BOTTLE (43353-112-60) 90 tablet2015-10-090000-00-00NoNoCurrent