FDA.reportPublic FDA data

Vivlodex

Product NDC
42211-205
11-digit product format
422110205
Labeler code
42211
Product ID
42211-205_56e0f811-6718-49ce-b054-c6ffd07545a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
meloxicam
Dosage form
CAPSULE
Route
ORAL
Labeler
Iroko Pharmaceuticals, LLC
Application
NDA207233
Marketing category
NDA
Marketing start
2015-10-31
Marketing end
0000-00-00
Substance
MELOXICAM
Active strength
5 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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bdef11ce-16e2-4690-96a3-597bcf5cc738Product name120260130
f2791553-0b76-42f4-8d49-af3eda072bfbProduct name120251117
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
3e9b4ed6-844c-4725-9d19-cceb5c823572Product name220210903
b21a682e-c765-4e26-9bb2-dbb8c7b38ef7Product name120200623
a428d1db-64d7-4fc3-8d13-832b1e84b683Product name120190201
96649a58-aac8-401c-be00-450b4335f7e7Product name120161116
f0761cb7-8207-3a19-2ca3-ecbb559b04e1Product name220161116

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42211-205-232021-01-29C16284748780-1ba0f9c33-3a38-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use VIVLODEX™ safely and effectively. See full prescribing information for VIVLODEX. VIVLODEX (meloxicam) capsules, for oral use Initial U.S. Approval: 2000
42211-205-292021-01-29C16284748780-1ba0f9c33-3a38-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use VIVLODEX™ safely and effectively. See full prescribing information for VIVLODEX. VIVLODEX (meloxicam) capsules, for oral use Initial U.S. Approval: 2000
42211-205-412021-01-29C16284748780-1ba0f9c33-3a38-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use VIVLODEX™ safely and effectively. See full prescribing information for VIVLODEX. VIVLODEX (meloxicam) capsules, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42211-205-23Vivlodex30 in 1 BOTTLECAPSULE304
42211-205-29Vivlodex90 in 1 BOTTLECAPSULE904
42211-205-41Vivlodex1 in 1 BLISTER PACKCAPSULE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42211-205-23EA - Each42211-2055dcf7375-6f4c-4573-8697-d74d51b124f512015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
meloxicamACTIVE INGREDIENTVG2QF83CGLVIVLODEX (MELOXICAM) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
meloxicamACTIVE MOIETYVG2QF83CGLVIVLODEX (MELOXICAM) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVIVLODEX (MELOXICAM) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VIVLODEX (MELOXICAM) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVIVLODEX (MELOXICAM) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
FD&C Red NO. 40INACTIVE INGREDIENTWZB9127XOAVIVLODEX (MELOXICAM) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
FD&C yellow NO. 6INACTIVE INGREDIENTH77VEI93A8VIVLODEX (MELOXICAM) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
GELATININACTIVE INGREDIENT2G86QN327LVIVLODEX (MELOXICAM) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVIVLODEX (MELOXICAM) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
PIGMENT RED 5INACTIVE INGREDIENT91OZU993LXVIVLODEX (MELOXICAM) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVIVLODEX (MELOXICAM) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIVIVLODEX (MELOXICAM) CAPSULE [IROKO PHARMACEUTICALS, LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVIVLODEX (MELOXICAM) CAPSULE [IROKO PHARMACEUTICALS, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42211-205VIVLODEX (MELOXICAM) CAPSULE [IROKO PHARMACEUTICALS, LLC]4Legacy NDC, 3 package rows20190411_fcfd6c24-98d0-4b7b-8336-936899ef61de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722357meloxicam 10 MG Oral CapsulePSNfcfd6c24-98d0-4b7b-8336-936899ef61de4
1722349meloxicam 5 MG Oral CapsulePSNfcfd6c24-98d0-4b7b-8336-936899ef61de4
1722359Vivlodex 10 MG Oral CapsulePSNfcfd6c24-98d0-4b7b-8336-936899ef61de4
1722355Vivlodex 5 MG Oral CapsulePSNfcfd6c24-98d0-4b7b-8336-936899ef61de4
1722359meloxicam 10 MG Oral Capsule [Vivlodex]SBDfcfd6c24-98d0-4b7b-8336-936899ef61de4
1722355meloxicam 5 MG Oral Capsule [Vivlodex]SBDfcfd6c24-98d0-4b7b-8336-936899ef61de4
1722357meloxicam 10 MG Oral CapsuleSCDfcfd6c24-98d0-4b7b-8336-936899ef61de4
1722349meloxicam 5 MG Oral CapsuleSCDfcfd6c24-98d0-4b7b-8336-936899ef61de4
1722359Vivlodex 10 MG Oral CapsuleSYfcfd6c24-98d0-4b7b-8336-936899ef61de4
1722355Vivlodex 5 MG Oral CapsuleSYfcfd6c24-98d0-4b7b-8336-936899ef61de4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42211-205-234221102052330 in 1 BOTTLEHistorical
42211-205-294221102052990 in 1 BOTTLEHistorical
42211-205-41422110205411 in 1 BLISTER PACKHistorical