FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
51655-043
11-digit product format
516550043
Labeler code
51655
Product ID
51655-043_46ddbacb-b899-1715-e063-6394a90a3c49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078216
Marketing category
ANDA
Marketing start
2021-03-24
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram Hydrobromide
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-043-522023-03-27C16284748780-1f386c649-a00b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998
51655-043-522023-01-30C16284748780-1f386c649-a00b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS. CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-043-26Citalopram Hydrobromide90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904
51655-043-52Citalopram Hydrobromide30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-043CITALOPRAM HYDROBROMIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 2 package rows20241215_c133fc77-6c8a-d2b1-e053-2995a90ab5f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSNc133fc77-6c8a-d2b1-e053-2995a90ab5f74
283672citalopram 10 MG Oral TabletSCDc133fc77-6c8a-d2b1-e053-2995a90ab5f74
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYc133fc77-6c8a-d2b1-e053-2995a90ab5f74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-043-265165500432690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-043-26) 2025-04-22NoNoCurrent
51655-043-525165500435230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-043-52) 2021-03-240000-00-00NoNoCurrent