FDA.reportPublic FDA data

Zorvolex

Product NDC
42211-204
11-digit product format
422110204
Labeler code
42211
Product ID
42211-204_73b05aef-df1b-4b6c-8409-021f697deae1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac
Dosage form
CAPSULE
Route
ORAL
Labeler
Iroko Pharmaceuticals LLC
Application
NDA204592
Marketing category
NDA
Marketing start
2013-10-31
Marketing end
0000-00-00
Substance
DICLOFENAC
Active strength
35 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],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
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42211-204-232021-01-29C16284748780-1ba0f9c33-43f2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ZORVOLEX ® safely and effectively. See full prescribing information for ZORVOLEX. ZORVOLEX (diclofenac) capsules, for oral use Initial U.S. Approval: 1988
42211-204-292021-01-29C16284748780-1ba0f9c33-43f2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ZORVOLEX ® safely and effectively. See full prescribing information for ZORVOLEX. ZORVOLEX (diclofenac) capsules, for oral use Initial U.S. Approval: 1988
42211-204-432021-01-29C16284748780-1ba0f9c33-43f2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ZORVOLEX ® safely and effectively. See full prescribing information for ZORVOLEX. ZORVOLEX (diclofenac) capsules, for oral use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42211-204-23Zorvolex30 in 1 BOTTLECAPSULE307
42211-204-29Zorvolex90 in 1 BOTTLECAPSULE907
42211-204-43Zorvolex1 in 1 CARTONCAPSULE17
42211-204-43Zorvolex3 in 1 BLISTER PACKCAPSULE37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42211-204-29EA - Each42211-20429c9e818-447a-4858-ac05-e62bb80e62c912013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENACACTIVE INGREDIENT144O8QL0L1ZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC]4
DICLOFENACACTIVE MOIETY144O8QL0L1ZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC]4
GELATININACTIVE INGREDIENT2G86QN327LZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC]4
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42211-204ZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC]7Legacy NDC, 4 package rows20190411_dff10e66-a577-451d-ba75-1889458ca833.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1442116diclofenac 18 MG Oral CapsulePSNdff10e66-a577-451d-ba75-1889458ca8337
1442128diclofenac 35 MG Oral CapsulePSNdff10e66-a577-451d-ba75-1889458ca8337
1442122Zorvolex 18 MG Oral CapsulePSNdff10e66-a577-451d-ba75-1889458ca8337
1442130Zorvolex 35 MG Oral CapsulePSNdff10e66-a577-451d-ba75-1889458ca8337
1442122diclofenac 18 MG Oral Capsule [Zorvolex]SBDdff10e66-a577-451d-ba75-1889458ca8337
1442130diclofenac 35 MG Oral Capsule [Zorvolex]SBDdff10e66-a577-451d-ba75-1889458ca8337
1442116diclofenac 18 MG Oral CapsuleSCDdff10e66-a577-451d-ba75-1889458ca8337
1442128diclofenac 35 MG Oral CapsuleSCDdff10e66-a577-451d-ba75-1889458ca8337
1442122Zorvolex 18 MG Oral CapsuleSYdff10e66-a577-451d-ba75-1889458ca8337
1442130Zorvolex 35 MG Oral CapsuleSYdff10e66-a577-451d-ba75-1889458ca8337

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42211-204-234221102042330 in 1 BOTTLEHistorical
42211-204-294221102042990 in 1 BOTTLEHistorical
42211-204-43422110204431 in 1 CARTONHistorical