Voltaren

Product NDC
63187-582
11-digit product format
631870582
Labeler code
63187
Product ID
63187-582_c57cc18e-48b1-4979-99f2-e66722aca356
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Proficient Rx LP
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QVOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]1
DICLOFENACACTIVE MOIETY144O8QL0L1VOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XVOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EVOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]1
COCO-CAPRYLATE/CAPRATEINACTIVE INGREDIENT8D9H4QU99HVOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302VOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPVOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYVOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RVOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-582VOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]3Legacy NDC20210113_9d6cf386-7fa1-433d-8fe9-4aa3617ba0e1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-582-00631870582001 TUBE in 1 CARTON (63187-582-00) > 100 g in 1 TUBE1 tube2018-12-010000-00-00NoNoCurrent