FDA.reportPublic FDA data

Citalopram

Product NDC
50090-3136
11-digit product format
500903136
Labeler code
50090
Product ID
50090-3136_327ed657-6e36-4573-87ca-65064e46db9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077031
Marketing category
ANDA
Marketing start
2004-10-28
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
50090-3136-02023-08-24C16284748780-1f386c649-f7e4-0266-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
50090-3136-22023-08-24C16284748780-1f386c649-f7e4-0266-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
50090-3136-02023-01-30C16284748780-1f386c649-f7e4-0266-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
50090-3136-22023-01-30C16284748780-1f386c649-f7e4-0266-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
50090-3136-0Citalopram30 in 1 BOTTLETABLET, FILM COATED3010
50090-3136-1Citalopram100 in 1 BOTTLETABLET, FILM COATED10010
50090-3136-2Citalopram90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3136-0EA - Each50090-3136128f94ec-740e-4104-b05d-f4c6613aca9812019-05-02
50090-3136-1EA - Each50090-3136bcb8c8b5-141c-452f-8851-d0bc87ea7da112024-03-12
50090-3136-2EA - Each50090-3136ac4c8bea-39ea-42f4-bd31-845fa2af0a0612019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3136CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 3 package rows20240215_c6730edc-7226-4521-a04a-1bf296b01b8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSNc6730edc-7226-4521-a04a-1bf296b01b8d10
309314citalopram 40 MG Oral TabletSCDc6730edc-7226-4521-a04a-1bf296b01b8d10
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYc6730edc-7226-4521-a04a-1bf296b01b8d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3136-05009031360030 TABLET, FILM COATED in 1 BOTTLE (50090-3136-0) 2017-09-130000-00-00NoNoCurrent
50090-3136-150090313601100 TABLET, FILM COATED in 1 BOTTLE (50090-3136-1) 2024-02-12NoNoHistorical
50090-3136-25009031360290 TABLET, FILM COATED in 1 BOTTLE (50090-3136-2) 2018-08-220000-00-00NoNoCurrent