Citalopram

Product NDC
0615-8022
11-digit product format
006158022
Labeler code
0615
Product ID
0615-8022_aec16083-ac47-4a94-83ca-412b543f477e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA077031
Marketing category
ANDA
Marketing start
2004-10-28
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
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 HYDROBROMIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui200371, 283672, 309314

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
0615-8022-05Citalopram15 in 1 BLISTER PACKTABLET, FILM COATED159
0615-8022-30Citalopram6 in 1 BOX, UNIT-DOSETABLET, FILM COATED69
0615-8022-30Citalopram5 in 1 BLISTER PACKTABLET, FILM COATED59
0615-8022-39Citalopram30 in 1 BLISTER PACKTABLET, FILM COATED309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8022CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]9Current NDC, Legacy NDC, 4 package rows20230908_fd761647-e16b-45b3-a4bc-364de0ed7015.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSNfd761647-e16b-45b3-a4bc-364de0ed70159
200371citalopram 20 MG Oral TabletPSNfd761647-e16b-45b3-a4bc-364de0ed70159
309314citalopram 40 MG Oral TabletPSNfd761647-e16b-45b3-a4bc-364de0ed70159
283672citalopram 10 MG Oral TabletSCDfd761647-e16b-45b3-a4bc-364de0ed70159
200371citalopram 20 MG Oral TabletSCDfd761647-e16b-45b3-a4bc-364de0ed70159
309314citalopram 40 MG Oral TabletSCDfd761647-e16b-45b3-a4bc-364de0ed70159
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYfd761647-e16b-45b3-a4bc-364de0ed70159
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYfd761647-e16b-45b3-a4bc-364de0ed70159
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYfd761647-e16b-45b3-a4bc-364de0ed70159

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8022-050061580220515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8022-05) 2004-10-280000-00-00NoNoCurrent
0615-8022-30006158022306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8022-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2004-10-280000-00-00NoNoCurrent
0615-8022-390061580223930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8022-39) 2004-10-280000-00-00NoNoCurrent