FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
50090-3208
11-digit product format
500903208
Labeler code
50090
Product ID
50090-3208_62db333a-b8cc-414a-b4c2-18bceabb8691
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078216
Marketing category
ANDA
Marketing start
2007-10-18
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram Hydrobromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui200371, 283672, 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3208-02023-02-07C16284748780-1f386c649-c6d0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
50090-3208-12023-02-07C16284748780-1f386c649-c6d0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
50090-3208-22023-02-07C16284748780-1f386c649-c6d0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
50090-3208-02023-01-30C16284748780-1f386c649-c6d0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
50090-3208-12023-01-30C16284748780-1f386c649-c6d0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
50090-3208-22023-01-30C16284748780-1f386c649-c6d0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3208-0Citalopram Hydrobromide30 in 1 BOTTLETABLET3032
50090-3208-1Citalopram Hydrobromide100 in 1 BOTTLETABLET10032
50090-3208-2Citalopram Hydrobromide90 in 1 BOTTLETABLET9032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3208-0EA - Each50090-320805469346-320e-4310-8f69-4a480059f65a12018-12-13
50090-3208-1EA - Each50090-32084fae9114-9077-40af-b1cc-ccebecd7aa2412018-12-13
50090-3208-2EA - Each50090-32081be49507-98a5-4fdd-a532-618a28a1170912018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3208CITALOPRAM HYDROBROMIDE TABLET [A-S MEDICATION SOLUTIONS]32Current NDC, Legacy NDC, 3 package rows20240926_05421bee-f746-418e-bb9c-ab44a89b567d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN05421bee-f746-418e-bb9c-ab44a89b567d32
200371citalopram 20 MG Oral TabletPSN05421bee-f746-418e-bb9c-ab44a89b567d32
309314citalopram 40 MG Oral TabletPSN05421bee-f746-418e-bb9c-ab44a89b567d32
283672citalopram 10 MG Oral TabletSCD05421bee-f746-418e-bb9c-ab44a89b567d32
200371citalopram 20 MG Oral TabletSCD05421bee-f746-418e-bb9c-ab44a89b567d32
309314citalopram 40 MG Oral TabletSCD05421bee-f746-418e-bb9c-ab44a89b567d32
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY05421bee-f746-418e-bb9c-ab44a89b567d32
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY05421bee-f746-418e-bb9c-ab44a89b567d32
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY05421bee-f746-418e-bb9c-ab44a89b567d32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3208-05009032080030 TABLET in 1 BOTTLE (50090-3208-0) 30 tablet2017-10-240000-00-00NoNoCurrent
50090-3208-150090320801100 TABLET in 1 BOTTLE (50090-3208-1) 100 tablet2017-10-260000-00-00NoNoCurrent
50090-3208-25009032080290 TABLET in 1 BOTTLE (50090-3208-2) 90 tablet2017-10-240000-00-00NoNoCurrent