FDA.reportPublic FDA data

Citalopram

Product NDC
50090-7419
11-digit product format
500907419
Labeler code
50090
Product ID
50090-7419_58b5618b-63bd-418e-9f18-36bc2cc271c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
Rxcui283672

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
50090-7419-0Citalopram100 in 1 BOTTLETABLET, FILM COATED10011
50090-7419-1Citalopram30 in 1 BOTTLETABLET, FILM COATED3011
50090-7419-2Citalopram90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7419-0EA - Each50090-7419518f3671-bb3d-4067-a8be-3f53d4dd6d8b12024-12-10
50090-7419-1EA - Each50090-74192f1348e9-ad23-4786-996e-3f6a4591fba512024-12-10
50090-7419-2EA - Each50090-74191912aa05-868a-4d6b-b4d0-028cb4430cc112024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7419CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, 3 package rows20241031_2500cc9d-a67d-46c5-9a76-99bc63959d67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN2500cc9d-a67d-46c5-9a76-99bc63959d6711
283672citalopram 10 MG Oral TabletSCD2500cc9d-a67d-46c5-9a76-99bc63959d6711
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY2500cc9d-a67d-46c5-9a76-99bc63959d6711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7419-050090741900100 TABLET, FILM COATED in 1 BOTTLE (50090-7419-0) 2024-10-28NoNoCurrent
50090-7419-15009074190130 TABLET, FILM COATED in 1 BOTTLE (50090-7419-1) 2024-10-28NoNoCurrent
50090-7419-25009074190290 TABLET, FILM COATED in 1 BOTTLE (50090-7419-2) 2024-10-28NoNoCurrent