FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
68071-2198
11-digit product format
680712198
Labeler code
68071
Product ID
68071-2198_1d75dc5e-3f66-d0c3-e063-6294a90aac2b
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
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 Hydrobromide
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2198-32024-07-17C16284748780-1ba0f9c33-1054-a910-e053-dadaa90a0b85Citalopram Tablets, USP
68071-2198-62024-07-17C16284748780-1ba0f9c33-1054-a910-e053-dadaa90a0b85Citalopram Tablets, USP
68071-2198-92024-07-17C16284748780-1ba0f9c33-1054-a910-e053-dadaa90a0b85Citalopram Tablets, USP
68071-2198-32023-01-30C16284748780-1ba0f9c33-1054-a910-e053-dadaa90a0b85Citalopram Tablets, USP
68071-2198-62023-01-30C16284748780-1ba0f9c33-1054-a910-e053-dadaa90a0b85Citalopram Tablets, USP
68071-2198-92023-01-30C16284748780-1ba0f9c33-1054-a910-e053-dadaa90a0b85Citalopram Tablets, USP
68071-2198-32021-02-23C16284748780-1ba0f9c33-1054-a910-e053-dadaa90a0b85Citalopram Tablets, USP
68071-2198-62021-02-23C16284748780-1ba0f9c33-1054-a910-e053-dadaa90a0b85Citalopram Tablets, USP
68071-2198-92021-02-23C16284748780-1ba0f9c33-1054-a910-e053-dadaa90a0b85Citalopram Tablets, USP
68071-2198-32021-01-29C16284748780-1ba0f9c33-1054-a910-e053-dadaa90a0b85Citalopram Tablets, USP
68071-2198-62021-01-29C16284748780-1ba0f9c33-1054-a910-e053-dadaa90a0b85Citalopram Tablets, USP
68071-2198-92021-01-29C16284748780-1ba0f9c33-1054-a910-e053-dadaa90a0b85Citalopram Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2198-3Citalopram Hydrobromide30 in 1 BOTTLETABLET304
68071-2198-6Citalopram Hydrobromide60 in 1 BOTTLETABLET604
68071-2198-9Citalopram Hydrobromide90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2198CITALOPRAM HYDROBROMIDE TABLET [NUCARE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20240719_4f45c818-b324-6ca6-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSN4f45c818-b324-6ca6-e054-00144ff8d46c4
200371citalopram 20 MG Oral TabletSCD4f45c818-b324-6ca6-e054-00144ff8d46c4
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY4f45c818-b324-6ca6-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2198-36807121980330 TABLET in 1 BOTTLE (68071-2198-3) 30 tablet2017-05-110000-00-00NoNoCurrent
68071-2198-66807121980660 TABLET in 1 BOTTLE (68071-2198-6) 60 tablet2017-05-110000-00-00NoNoCurrent
68071-2198-96807121980990 TABLET in 1 BOTTLE (68071-2198-9) 90 tablet2017-05-110000-00-00NoNoCurrent