FDA.reportPublic FDA data

Citalopram

Product NDC
31722-208
11-digit product format
317220208
Labeler code
31722
Product ID
31722-208_d16fcdcc-14b9-430f-9b14-900f8c2d3f84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals
Application
ANDA077534
Marketing category
ANDA
Marketing start
2011-01-01
Marketing end
0000-00-00
Substance
CITALOPRAM HYDROBROMIDE
Active strength
40 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
31722-208-012025-02-19C16284748780-19d75b9d0-b2fc-f424-e053-dadaa90a57ceb05c85d1-2474-4803-a0c0-585d5f764d4b
31722-208-052025-02-19C16284748780-19d75b9d0-b2fc-f424-e053-dadaa90a57ceb05c85d1-2474-4803-a0c0-585d5f764d4b
31722-208-102025-02-19C16284748780-19d75b9d0-b2fc-f424-e053-dadaa90a57ceb05c85d1-2474-4803-a0c0-585d5f764d4b
31722-208-012020-01-31C16284748780-19d75b9d0-b2fc-f424-e053-dadaa90a57ceb05c85d1-2474-4803-a0c0-585d5f764d4b
31722-208-052020-01-31C16284748780-19d75b9d0-b2fc-f424-e053-dadaa90a57ceb05c85d1-2474-4803-a0c0-585d5f764d4b
31722-208-102020-01-31C16284748780-19d75b9d0-b2fc-f424-e053-dadaa90a57ceb05c85d1-2474-4803-a0c0-585d5f764d4b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-208-01EA - Each31722-2084c058c7f-4af0-4149-ba88-2efcb7cd251b12012-07-24
31722-208-05EA - Each31722-2085f466ffc-1d03-41d3-9c76-9fda28dd416312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET [REBEL DISTRIBUTORS CORP]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM TABLET [REBEL DISTRIBUTORS CORP]1
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BCITALOPRAM TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82CITALOPRAM TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCITALOPRAM TABLET [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCITALOPRAM TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSN17b2ac2b-f709-433b-961f-57a8dbe1c36a1
309314citalopram 40 MG Oral TabletSCD17b2ac2b-f709-433b-961f-57a8dbe1c36a1
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY17b2ac2b-f709-433b-961f-57a8dbe1c36a1