FDA.reportPublic FDA data

Voltaren

Product NDC
50436-3621
11-digit product format
504363621
Labeler code
50436
Product ID
50436-3621_45470c3b-f437-4380-a9a4-85a16a30ee18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Unit Dose Services
Application
NDA022122
Marketing category
NDA
Marketing start
2007-10-17
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
10 mg/g
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
50436-3621-12021-01-29C16284748780-1ba0f9c33-5579-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use VOLTAREN ® GEL safely and effectively. See full prescribing information for VOLTAREN ® GEL. VOLTAREN ® GEL (diclofenac sodium topical gel), 1%, for topical use only Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3621-1Voltaren1 in 1 CARTONGEL15
50436-3621-1Voltaren100 g in 1 TUBEGEL1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-3621-1GM - Gram50436-362103eb6b11-4a07-43fb-ab0c-ea2c28d7f3e012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QVOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]2
DICLOFENACACTIVE MOIETY144O8QL0L1VOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XVOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]2
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EVOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302VOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPVOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]2
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYVOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]2
WATERINACTIVE INGREDIENT059QF0KO0RVOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3621VOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]5Legacy NDC, 2 package rows20170829_ea23fc47-3b7b-4fad-ae34-b6eb6913d957.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSNea23fc47-3b7b-4fad-ae34-b6eb6913d9575
855635Voltaren 1 % Topical GelPSNea23fc47-3b7b-4fad-ae34-b6eb6913d9575
855635diclofenac sodium 0.01 MG/MG Topical Gel [Voltaren]SBDea23fc47-3b7b-4fad-ae34-b6eb6913d9575
855633diclofenac sodium 0.01 MG/MG Topical GelSCDea23fc47-3b7b-4fad-ae34-b6eb6913d9575
855633diclofenac sodium 1 % Topical GelSYea23fc47-3b7b-4fad-ae34-b6eb6913d9575
855635Voltaren 0.01 MG/MG Topical GelSYea23fc47-3b7b-4fad-ae34-b6eb6913d9575
855635Voltaren 1 % Topical GelSYea23fc47-3b7b-4fad-ae34-b6eb6913d9575

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-3621-1504363621011 in 1 CARTONHistorical