Citalopram Hydrobromide

Product NDC
68071-2459
11-digit product format
680712459
Labeler code
68071
Product ID
68071-2459_2c6523b5-e13b-51f9-e063-6394a90a2f84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078216
Marketing category
ANDA
Marketing start
2007-10-18
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 Hydrobromide
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2459-12025-01-23C16284748780-1f386c649-c6a5-0266-e053-dadaa90a7c1aCitalopram Tablets, USP
68071-2459-12023-01-30C16284748780-1f386c649-c6a5-0266-e053-dadaa90a7c1aCitalopram Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2459-1Citalopram Hydrobromide100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2459CITALOPRAM HYDROBROMIDE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 1 package rows20250125_c577b306-ee7c-8364-e053-2a95a90abb13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSNc577b306-ee7c-8364-e053-2a95a90abb132
283672citalopram 10 MG Oral TabletSCDc577b306-ee7c-8364-e053-2a95a90abb132
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYc577b306-ee7c-8364-e053-2a95a90abb132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2459-168071245901100 TABLET in 1 BOTTLE (68071-2459-1) 100 tablet2021-06-240000-00-00NoNoCurrent