FDA.reportPublic FDA data

Citalopram

Product NDC
62135-540
11-digit product format
621350540
Labeler code
62135
Product ID
62135-540_4a2ccdf3-3193-9182-e063-6294a90ad893
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA077629
Marketing category
ANDA
Marketing start
2006-06-14
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
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/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
62135-540-10Citalopram10 mL in 1 CUPSOLUTION106
62135-540-24Citalopram10 in 1 TRAYSOLUTION106
62135-540-24Citalopram2 in 1 BOXSOLUTION26
62135-540-47Citalopram473 mL in 1 BOTTLESOLUTION4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-540CITALOPRAM SOLUTION [CHARTWELL RX, LLC]5Current NDC, Legacy NDC, 4 package rows20250410_b1f0c6e8-85eb-4368-8709-9cace32415cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309313citalopram 10 MG in 5 mL Oral SolutionPSNb1f0c6e8-85eb-4368-8709-9cace32415cb6
309313citalopram 2 MG/ML Oral SolutionSCDb1f0c6e8-85eb-4368-8709-9cace32415cb6
309313citalopram (as citalopram hydrobromide) 2 MG/ML Oral SolutionSYb1f0c6e8-85eb-4368-8709-9cace32415cb6
309313citalopram 10 MG per 5 ML Oral SolutionSYb1f0c6e8-85eb-4368-8709-9cace32415cb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-540-106213505401010 mL in 1 CUP10 mlHistorical
62135-540-24621350540242 TRAY in 1 BOX (62135-540-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-540-10) 2 tray2025-04-03NoNoCurrent
62135-540-4762135054047473 mL in 1 BOTTLE (62135-540-47) 473 ml2022-10-310000-00-00NoNoCurrent