FDA.reportPublic FDA data

Citalopram

Product NDC
50090-5172
11-digit product format
500905172
Labeler code
50090
Product ID
50090-5172_3edc302b-9e97-403f-95fd-6c48d227de39
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
20 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 HYDROBROMIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui200371

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
50090-5172-02023-02-07C16284748780-1f386c649-b002-0266-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
50090-5172-12023-02-07C16284748780-1f386c649-b002-0266-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
50090-5172-22023-02-07C16284748780-1f386c649-b002-0266-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
50090-5172-32023-02-07C16284748780-1f386c649-b002-0266-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
50090-5172-02023-01-30C16284748780-1f386c649-b002-0266-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
50090-5172-12023-01-30C16284748780-1f386c649-b002-0266-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
50090-5172-22023-01-30C16284748780-1f386c649-b002-0266-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
50090-5172-32023-01-30C16284748780-1f386c649-b002-0266-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
50090-5172-0Citalopram30 in 1 BOTTLETABLET307
50090-5172-1Citalopram60 in 1 BOTTLETABLET607
50090-5172-2Citalopram100 in 1 BOTTLETABLET1007
50090-5172-3Citalopram90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5172-0EA - Each50090-5172f979a5d3-339e-475e-a222-f6ee721e3e2d12022-12-07
50090-5172-1EA - Each50090-5172abc33ba2-20e0-41a7-b4e8-d0e857601ca512024-06-10
50090-5172-2EA - Each50090-517298c18116-3e28-4b6a-886b-e6cb2cc0fcb512022-12-07
50090-5172-3EA - Each50090-51723bd67b43-c2fe-450a-8966-623ab33fb49112022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5172CITALOPRAM TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 4 package rows20240501_c91684c7-fddb-4cf0-9711-b0484c8c7e8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSNc91684c7-fddb-4cf0-9711-b0484c8c7e8b7
200371citalopram 20 MG Oral TabletSCDc91684c7-fddb-4cf0-9711-b0484c8c7e8b7
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYc91684c7-fddb-4cf0-9711-b0484c8c7e8b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5172-05009051720030 TABLET in 1 BOTTLE (50090-5172-0) 30 tablet2020-09-250000-00-00NoNoCurrent
50090-5172-15009051720160 TABLET in 1 BOTTLE (50090-5172-1) 60 tablet2020-09-250000-00-00NoNoCurrent
50090-5172-250090517202100 TABLET in 1 BOTTLE (50090-5172-2) 100 tablet2020-09-250000-00-00NoNoCurrent
50090-5172-35009051720390 TABLET in 1 BOTTLE (50090-5172-3) 90 tablet2020-09-250000-00-00NoNoCurrent