Citalopram

Product NDC
70518-4114
11-digit product format
705184114
Labeler code
70518
Product ID
70518-4114_4c9aaeeb-23aa-db78-e063-6394a90ae3c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077031
Marketing category
ANDA
Marketing start
2024-06-26
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
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 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
70518-4114-0Citalopram30 in 1 BLISTER PACKTABLET, FILM COATED304
70518-4114-1Citalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4114CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [REMEDYREPACK INC.]1Current NDC, 2 package rows20240629_625a78b2-4751-4ca5-91b6-7c85fd9f8c2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSN625a78b2-4751-4ca5-91b6-7c85fd9f8c2e4
200371citalopram 20 MG Oral TabletSCD625a78b2-4751-4ca5-91b6-7c85fd9f8c2e4
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY625a78b2-4751-4ca5-91b6-7c85fd9f8c2e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4114-07051841140030 in 1 BLISTER PACKHistorical
70518-4114-17051841140190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4114-1) 2026-01-18NoNoHistorical