FDA.reportPublic FDA data

Citalopram

Product NDC
50090-5170
11-digit product format
500905170
Labeler code
50090
Product ID
50090-5170_ebbb61db-78fc-4f15-b0c2-d6e578c12014
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077534
Marketing category
ANDA
Marketing start
2016-07-22
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui283672

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
50090-5170-02023-02-06C16284748780-1f386c649-ca9e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CITALOPRAM® safely and effectively. See full prescribing information for CITALOPRAM®. Citalopram Tablets, for oral use Initial U.S. Approval: 1998
50090-5170-12023-02-06C16284748780-1f386c649-ca9e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CITALOPRAM® safely and effectively. See full prescribing information for CITALOPRAM®. Citalopram Tablets, for oral use Initial U.S. Approval: 1998
50090-5170-22023-02-06C16284748780-1f386c649-ca9e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CITALOPRAM® safely and effectively. See full prescribing information for CITALOPRAM®. Citalopram Tablets, for oral use Initial U.S. Approval: 1998
50090-5170-02023-01-30C16284748780-1f386c649-ca9e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CITALOPRAM® safely and effectively. See full prescribing information for CITALOPRAM®. Citalopram Tablets, for oral use Initial U.S. Approval: 1998
50090-5170-12023-01-30C16284748780-1f386c649-ca9e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CITALOPRAM® safely and effectively. See full prescribing information for CITALOPRAM®. Citalopram Tablets, for oral use Initial U.S. Approval: 1998
50090-5170-22023-01-30C16284748780-1f386c649-ca9e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CITALOPRAM® safely and effectively. See full prescribing information for CITALOPRAM®. Citalopram Tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5170-0Citalopram100 in 1 BOTTLETABLET1007
50090-5170-1Citalopram30 in 1 BOTTLETABLET307
50090-5170-2Citalopram90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5170CITALOPRAM TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 3 package rows20240501_04ac5286-fc2e-4990-a574-ea21131ef731.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN04ac5286-fc2e-4990-a574-ea21131ef7317
283672citalopram 10 MG Oral TabletSCD04ac5286-fc2e-4990-a574-ea21131ef7317
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY04ac5286-fc2e-4990-a574-ea21131ef7317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5170-050090517000100 TABLET in 1 BOTTLE (50090-5170-0) 100 tablet2020-09-250000-00-00NoNoCurrent
50090-5170-15009051700130 TABLET in 1 BOTTLE (50090-5170-1) 30 tablet2020-09-250000-00-00NoNoCurrent
50090-5170-25009051700290 TABLET in 1 BOTTLE (50090-5170-2) 90 tablet2020-09-250000-00-00NoNoCurrent