FDA.reportPublic FDA data

Citalopram

Product NDC
51655-209
11-digit product format
516550209
Labeler code
51655
Product ID
51655-209_48d2a0a2-f269-ef1d-e063-6394a90a49c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA077534
Marketing category
ANDA
Marketing start
2022-10-21
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-209-26Citalopram90 in 1 BOTTLE, PLASTICTABLET904
51655-209-52Citalopram30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-209CITALOPRAM TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20241218_f2b54f10-221f-5eed-e053-2995a90ab47f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSNf2b54f10-221f-5eed-e053-2995a90ab47f4
309314citalopram 40 MG Oral TabletSCDf2b54f10-221f-5eed-e053-2995a90ab47f4
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYf2b54f10-221f-5eed-e053-2995a90ab47f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-209-265165502092690 TABLET in 1 BOTTLE, PLASTIC (51655-209-26) 90 tablet2022-10-21NoNoCurrent
51655-209-525165502095230 TABLET in 1 BOTTLE, PLASTIC (51655-209-52) 30 tablet2023-01-03NoNoCurrent