FDA.reportPublic FDA data

Citalopram

Product NDC
51655-137
11-digit product format
516550137
Labeler code
51655
Product ID
51655-137_48c3e3f2-09c2-c403-e063-6294a90aafde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA077534
Marketing category
ANDA
Marketing start
2022-10-04
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-137-26Citalopram90 in 1 BOTTLE, PLASTICTABLET904
51655-137-52Citalopram30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-137CITALOPRAM TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20241215_f2b42bdc-47e0-19c5-e053-2a95a90a1828.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSNf2b42bdc-47e0-19c5-e053-2a95a90a18284
200371citalopram 20 MG Oral TabletSCDf2b42bdc-47e0-19c5-e053-2a95a90a18284
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYf2b42bdc-47e0-19c5-e053-2a95a90a18284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-137-265165501372690 TABLET in 1 BOTTLE, PLASTIC (51655-137-26) 90 tablet2023-01-19NoNoCurrent
51655-137-525165501375230 TABLET in 1 BOTTLE, PLASTIC (51655-137-52) 30 tablet2022-10-04NoNoCurrent