FDA.reportPublic FDA data

Citalopram

Product NDC
80425-0093
11-digit product format
804250093
Labeler code
80425
Product ID
80425-0093_2a996b2b-b5d6-65e7-e063-6394a90adeed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA078216
Marketing category
ANDA
Marketing start
2007-10-18
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
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 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
80425-0093-1Citalopram30 in 1 BOTTLETABLET306
80425-0093-2Citalopram60 in 1 BOTTLETABLET606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0093-1EA - Each80425-009366a94885-b495-4153-be87-3e426b1d340f12023-03-13
80425-0093-2EA - Each80425-00934598dc05-575c-4264-a828-8903010237d512023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0093CITALOPRAM TABLET [ADVANCED RX OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_b3541f26-dc8d-6591-e053-2995a90a23d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSNb3541f26-dc8d-6591-e053-2995a90a23d96
200371citalopram 20 MG Oral TabletSCDb3541f26-dc8d-6591-e053-2995a90a23d96
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYb3541f26-dc8d-6591-e053-2995a90a23d96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0093-18042500930130 TABLET in 1 BOTTLE (80425-0093-1) 30 tablet2007-10-180000-00-00NoNoCurrent
80425-0093-28042500930260 TABLET in 1 BOTTLE (80425-0093-2) 60 tablet2007-10-180000-00-00NoNoCurrent