FDA.reportPublic FDA data

VOLTAREN

Product NDC
61919-592
11-digit product format
619190592
Labeler code
61919
Product ID
61919-592_9441684a-4941-406f-a4a3-c9d996285bd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VOLTAREN
Dosage form
GEL
Route
TOPICAL
Labeler
DIRECT RX
Application
NDA022122
Marketing category
NDA
Marketing start
2015-01-01
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
E
Listing certified through
2017-12-31
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
61919-592-012020-01-31C16284748780-19d75b9d0-794e-f424-e053-dadaa90a57ceVOLTAREN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-592-01VOLTAREN100 g in 1 TUBEGEL1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-592-01GM - Gram61919-59226e483f8-10ac-4428-aa58-eb6e62ef23fc12014-07-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-592VOLTAREN GEL [DIRECT RX]2Legacy NDC, 1 package rows20150810_b04009ca-7545-4cd4-af63-f15aebf20f18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSNb04009ca-7545-4cd4-af63-f15aebf20f182
855633diclofenac sodium 0.01 MG/MG Topical GelSCDb04009ca-7545-4cd4-af63-f15aebf20f182
855633diclofenac sodium 1 % Topical GelSYb04009ca-7545-4cd4-af63-f15aebf20f182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
61919-592-0161919059201100 g in 1 TUBE100 gHistorical