FDA.reportPublic FDA data

Citalopram

Product NDC
13107-005
11-digit product format
131070005
Labeler code
13107
Product ID
13107-005_2627f188-05c8-44ac-845e-80678a0c2fdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma LLC
Application
ANDA077031
Marketing category
ANDA
Marketing start
2009-01-01
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
E
Listing certified through
2018-12-31
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
13107-005-012020-01-31C16284748780-19d75b9d0-5b30-f424-e053-dadaa90a57ce9f5a14c2-b460-402e-acb4-04402278e64b
13107-005-052020-01-31C16284748780-19d75b9d0-5b30-f424-e053-dadaa90a57ce9f5a14c2-b460-402e-acb4-04402278e64b
13107-005-102020-01-31C16284748780-19d75b9d0-5b30-f424-e053-dadaa90a57ce9f5a14c2-b460-402e-acb4-04402278e64b
13107-005-302020-01-31C16284748780-19d75b9d0-5b30-f424-e053-dadaa90a57ce9f5a14c2-b460-402e-acb4-04402278e64b
13107-005-322020-01-31C16284748780-19d75b9d0-5b30-f424-e053-dadaa90a57ce9f5a14c2-b460-402e-acb4-04402278e64b
13107-005-602020-01-31C16284748780-19d75b9d0-5b30-f424-e053-dadaa90a57ce9f5a14c2-b460-402e-acb4-04402278e64b
13107-005-902020-01-31C16284748780-19d75b9d0-5b30-f424-e053-dadaa90a57ce9f5a14c2-b460-402e-acb4-04402278e64b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-005-01Citalopram100 in 1 BOTTLETABLET1002
13107-005-05Citalopram500 in 1 BOTTLETABLET5002
13107-005-10Citalopram100 in 1 CARTONTABLET1002
13107-005-10Citalopram10 in 1 BLISTER PACKTABLET102
13107-005-30Citalopram30 in 1 BOTTLETABLET302
13107-005-32Citalopram30 in 1 BLISTER PACKTABLET302
13107-005-60Citalopram60 in 1 BOTTLETABLET602
13107-005-90Citalopram90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-005-01EA - Each13107-005842d7a4f-994f-4b69-8e24-09641559019812012-07-24
13107-005-05EA - Each13107-005588cb88f-79b9-4094-a28d-39d4c5b811ca12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BCITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM TABLET [AUROLIFE PHARMA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET [AUROLIFE PHARMA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-005CITALOPRAM TABLET [AUROLIFE PHARMA LLC]2Legacy NDC, 8 package rows20120510_9f5a14c2-b460-402e-acb4-04402278e64b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN9f5a14c2-b460-402e-acb4-04402278e64b2
200371citalopram 20 MG Oral TabletPSN9f5a14c2-b460-402e-acb4-04402278e64b2
309314citalopram 40 MG Oral TabletPSN9f5a14c2-b460-402e-acb4-04402278e64b2
283672citalopram 10 MG Oral TabletSCD9f5a14c2-b460-402e-acb4-04402278e64b2
200371citalopram 20 MG Oral TabletSCD9f5a14c2-b460-402e-acb4-04402278e64b2
309314citalopram 40 MG Oral TabletSCD9f5a14c2-b460-402e-acb4-04402278e64b2
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY9f5a14c2-b460-402e-acb4-04402278e64b2
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY9f5a14c2-b460-402e-acb4-04402278e64b2
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY9f5a14c2-b460-402e-acb4-04402278e64b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
13107-005-0113107000501100 in 1 BOTTLEHistorical
13107-005-0513107000505500 in 1 BOTTLEHistorical
13107-005-1013107000510100 in 1 CARTONHistorical
13107-005-301310700053030 in 1 BOTTLEHistorical
13107-005-321310700053230 in 1 BLISTER PACKHistorical
13107-005-601310700056060 in 1 BOTTLEHistorical
13107-005-901310700059090 in 1 BOTTLEHistorical