Citalopram

Product NDC
51655-605
11-digit product format
516550605
Labeler code
51655
Product ID
51655-605_494f25f9-6036-798e-e063-6294a90ab59f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA077031
Marketing category
ANDA
Marketing start
2021-04-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-605-26Citalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904
51655-605-52Citalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-605CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20241228_d9cc1649-913d-832d-e053-2995a90a5f9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSNd9cc1649-913d-832d-e053-2995a90a5f9a4
283672citalopram 10 MG Oral TabletSCDd9cc1649-913d-832d-e053-2995a90a5f9a4
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYd9cc1649-913d-832d-e053-2995a90a5f9a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-605-265165506052690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-605-26) 2022-03-02NoNoCurrent
51655-605-525165506055230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-605-52) 2021-04-01NoNoCurrent