FDA.reportPublic FDA data

Citalopram

Product NDC
51655-938
11-digit product format
516550938
Labeler code
51655
Product ID
51655-938_4bc10b42-41a8-0d11-e063-6394a90aa4e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA077534
Marketing category
ANDA
Marketing start
2022-07-27
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram
Listing expiration
2027-12-31

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
51655-938-262026-01-29C16284748780-149896155-b926-586f-e063-e6dba90add90These 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
51655-938-522026-01-29C16284748780-149896155-b926-586f-e063-e6dba90add90These 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
51655-938-26Citalopram90 in 1 BOTTLE, PLASTICTABLET904
51655-938-52Citalopram30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-938CITALOPRAM TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240814_f77ef23b-3015-d074-e053-6394a90a11e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSNf77ef23b-3015-d074-e053-6394a90a11e14
283672citalopram 10 MG Oral TabletSCDf77ef23b-3015-d074-e053-6394a90a11e14
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYf77ef23b-3015-d074-e053-6394a90a11e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-938-265165509382690 TABLET in 1 BOTTLE, PLASTIC (51655-938-26) 90 tablet2022-07-27NoNoCurrent
51655-938-525165509385230 TABLET in 1 BOTTLE, PLASTIC (51655-938-52) 30 tablet2022-08-26NoNoCurrent