FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
33261-026
11-digit product format
332610026
Labeler code
33261
Product ID
33261-026_11d5faa0-145f-45b8-a386-b17d0ef240d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078216
Marketing category
ANDA
Marketing start
2007-10-18
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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
33261-026-302020-01-31C16284748780-19d75b9d1-24b4-f424-e053-dadaa90a57ceCitalopram Tablets USP
33261-026-602020-01-31C16284748780-19d75b9d1-24b4-f424-e053-dadaa90a57ceCitalopram Tablets USP
33261-026-902020-01-31C16284748780-19d75b9d1-24b4-f424-e053-dadaa90a57ceCitalopram Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-026-30Citalopram Hydrobromide30 in 1 BOTTLE, PLASTICTABLET301
33261-026-60Citalopram Hydrobromide60 in 1 BOTTLE, PLASTICTABLET601
33261-026-90Citalopram Hydrobromide90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-026-30EA - Each33261-026318c32eb-4ab0-40f8-809b-cac4000bc3be12015-10-02
33261-026-60EA - Each33261-026806862bd-fb9d-4992-a4d2-f0834334e60b12015-10-02
33261-026-90EA - Each33261-026d13e0544-e2df-4120-ab84-91b8d6fb357912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-026CITALOPRAM HYDROBROMIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140102_16715e29-86e8-48b3-8c12-da70e5893901.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN16715e29-86e8-48b3-8c12-da70e58939011
200371citalopram 20 MG Oral TabletPSN16715e29-86e8-48b3-8c12-da70e58939011
309314citalopram 40 MG Oral TabletPSN16715e29-86e8-48b3-8c12-da70e58939011
283672citalopram 10 MG Oral TabletSCD16715e29-86e8-48b3-8c12-da70e58939011
200371citalopram 20 MG Oral TabletSCD16715e29-86e8-48b3-8c12-da70e58939011
309314citalopram 40 MG Oral TabletSCD16715e29-86e8-48b3-8c12-da70e58939011
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY16715e29-86e8-48b3-8c12-da70e58939011
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY16715e29-86e8-48b3-8c12-da70e58939011
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY16715e29-86e8-48b3-8c12-da70e58939011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-026-303326100263030 in 1 BOTTLE, PLASTICHistorical
33261-026-603326100266060 in 1 BOTTLE, PLASTICHistorical
33261-026-903326100269090 in 1 BOTTLE, PLASTICHistorical