FDA.reportPublic FDA data

Citalopram

Product NDC
50090-5175
11-digit product format
500905175
Labeler code
50090
Product ID
50090-5175_af397ebb-a113-42d3-90d4-e8600b25809b
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
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui309314

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
50090-5175-02023-02-06C16284748780-1f386c649-a7ed-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
50090-5175-12023-02-06C16284748780-1f386c649-a7ed-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
50090-5175-22023-02-06C16284748780-1f386c649-a7ed-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
50090-5175-02023-01-30C16284748780-1f386c649-a7ed-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
50090-5175-12023-01-30C16284748780-1f386c649-a7ed-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
50090-5175-22023-01-30C16284748780-1f386c649-a7ed-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
50090-5175-0Citalopram30 in 1 BOTTLETABLET307
50090-5175-1Citalopram100 in 1 BOTTLETABLET1007
50090-5175-2Citalopram90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5175-0EA - Each50090-5175cf40af91-316b-41bd-ad32-7857b884663912023-04-07
50090-5175-1EA - Each50090-517591286859-f1b1-4aeb-ae1f-54e06b8f09b512023-04-07
50090-5175-2EA - Each50090-517553c43234-4102-41e3-9b15-9fb02059705512023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5175CITALOPRAM TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 3 package rows20240501_17af7a8d-ef57-4253-96ed-e457e0062eb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSN17af7a8d-ef57-4253-96ed-e457e0062eb57
309314citalopram 40 MG Oral TabletSCD17af7a8d-ef57-4253-96ed-e457e0062eb57
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY17af7a8d-ef57-4253-96ed-e457e0062eb57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5175-05009051750030 TABLET in 1 BOTTLE (50090-5175-0) 30 tablet2020-09-250000-00-00NoNoCurrent
50090-5175-150090517501100 TABLET in 1 BOTTLE (50090-5175-1) 100 tablet2020-09-250000-00-00NoNoCurrent
50090-5175-25009051750290 TABLET in 1 BOTTLE (50090-5175-2) 90 tablet2020-09-250000-00-00NoNoCurrent