Citalopram Hydrobromide

Product NDC
65862-074
11-digit product format
658620074
Labeler code
65862
Product ID
65862-074_7cecadcf-9da0-41e4-b9fd-0fe04572dcd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
SOLUTION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077812
Marketing category
ANDA
Marketing start
2006-08-28
Substance
CITALOPRAM HYDROBROMIDE
Active strength
10 mg/5mL
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 Hydrobromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE10 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui309313

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
65862-074-24Citalopram Hydrobromide240 mL in 1 BOTTLESOLUTION24019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-074-24ML - Milliliter65862-0744f2b6dc7-9d74-42f7-a5ff-365f5ab25d0e12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-074CITALOPRAM HYDROBROMIDE SOLUTION [AUROBINDO PHARMA LIMITED]19Current NDC, Legacy NDC, 1 package rows20240509_e7a2cbdd-1bdb-4e59-a3dd-298a189753ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309313citalopram 10 MG in 5 mL Oral SolutionPSNe7a2cbdd-1bdb-4e59-a3dd-298a189753ae19
309313citalopram 2 MG/ML Oral SolutionSCDe7a2cbdd-1bdb-4e59-a3dd-298a189753ae19
309313citalopram (as citalopram hydrobromide) 2 MG/ML Oral SolutionSYe7a2cbdd-1bdb-4e59-a3dd-298a189753ae19
309313citalopram 10 MG per 5 ML Oral SolutionSYe7a2cbdd-1bdb-4e59-a3dd-298a189753ae19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-074-2465862007424240 mL in 1 BOTTLE (65862-074-24) 240 ml2006-08-280000-00-00NoNoCurrent