FDA.reportPublic FDA data

Tivorbex

Product NDC
42211-202
11-digit product format
422110202
Labeler code
42211
Product ID
42211-202_8a792cbe-8874-4655-a1e7-ca9007eee950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
indomethacin
Dosage form
CAPSULE
Route
ORAL
Labeler
Iroko Pharmaceuticals, LLC
Application
NDA204768
Marketing category
NDA
Marketing start
2015-07-06
Marketing end
0000-00-00
Substance
INDOMETHACIN
Active strength
40 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
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
234b5275-84d6-d169-e08f-554a8aed3f0aProduct name320250717
9aaf7cf4-60c3-b44f-e302-fd8b276c713bProduct name220250107
c6b2f0e9-1a13-02e4-f789-55c724469f07Product name720171115
6e9718b9-62b9-458f-9408-30d688800922Product name120171103
d62774ab-b1b9-2d5c-924f-1948e411ae15Product name320170816
97c70338-ee37-4c78-a047-53ee1cd9b53dProduct name120150616

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42211-202-232020-01-31C16284748780-19d75b9d1-199e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TIVORBEX ® safely and effectively. See full prescribing information for TIVORBEX . TIVORBEX ( indomethacin ) Capsules , for oral use Initial U.S. Approval: 1965
42211-202-292020-01-31C16284748780-19d75b9d1-199e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TIVORBEX ® safely and effectively. See full prescribing information for TIVORBEX . TIVORBEX ( indomethacin ) Capsules , for oral use Initial U.S. Approval: 1965
42211-202-422020-01-31C16284748780-19d75b9d1-199e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TIVORBEX ® safely and effectively. See full prescribing information for TIVORBEX . TIVORBEX ( indomethacin ) Capsules , for oral use Initial U.S. Approval: 1965
42211-202-432020-01-31C16284748780-19d75b9d1-199e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use TIVORBEX ® safely and effectively. See full prescribing information for TIVORBEX . TIVORBEX ( indomethacin ) Capsules , for oral use Initial U.S. Approval: 1965

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42211-202-23Tivorbex30 in 1 BOTTLECAPSULE307
42211-202-29Tivorbex90 in 1 BOTTLECAPSULE907
42211-202-42Tivorbex2 in 1 BLISTER PACKCAPSULE27
42211-202-42Tivorbex1 in 1 CARTONCAPSULE17
42211-202-43Tivorbex3 in 1 BLISTER PACKCAPSULE37
42211-202-43Tivorbex1 in 1 CARTONCAPSULE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42211-202-29EA - Each42211-20280676ce6-051d-4077-9651-d0ddd19f6af612015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
indomethacinACTIVE INGREDIENTXXE1CET956TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
indomethacinACTIVE MOIETYXXE1CET956TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
GELATININACTIVE INGREDIENT2G86QN327LTIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UITIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42211-202TIVORBEX (INDOMETHACIN) CAPSULE [IROKO PHARMACEUTICALS, LLC]7Legacy NDC, 6 package rows20180221_04ca474c-798e-43dd-be7a-1b36720e6a3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490727indomethacin 20 MG Oral CapsulePSN04ca474c-798e-43dd-be7a-1b36720e6a3d7
1491529indomethacin 40 MG Oral CapsulePSN04ca474c-798e-43dd-be7a-1b36720e6a3d7
1491527Tivorbex 20 MG Oral CapsulePSN04ca474c-798e-43dd-be7a-1b36720e6a3d7
1491531Tivorbex 40 MG Oral CapsulePSN04ca474c-798e-43dd-be7a-1b36720e6a3d7
1491527indomethacin 20 MG Oral Capsule [Tivorbex]SBD04ca474c-798e-43dd-be7a-1b36720e6a3d7
1491531indomethacin 40 MG Oral Capsule [Tivorbex]SBD04ca474c-798e-43dd-be7a-1b36720e6a3d7
1490727indomethacin 20 MG Oral CapsuleSCD04ca474c-798e-43dd-be7a-1b36720e6a3d7
1491529indomethacin 40 MG Oral CapsuleSCD04ca474c-798e-43dd-be7a-1b36720e6a3d7
1491527Tivorbex 20 MG Oral CapsuleSY04ca474c-798e-43dd-be7a-1b36720e6a3d7
1491531Tivorbex 40 MG Oral CapsuleSY04ca474c-798e-43dd-be7a-1b36720e6a3d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42211-202-234221102022330 in 1 BOTTLEHistorical
42211-202-294221102022990 in 1 BOTTLEHistorical
42211-202-42422110202422 in 1 BLISTER PACKHistorical
42211-202-43422110202433 in 1 BLISTER PACKHistorical