Diclofenac sodium

Product NDC
70518-3464
11-digit product format
705183464
Labeler code
70518
Product ID
70518-3464_e67588f0-d7f6-c5c2-e053-2995a90ab7a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
REMEDYREPACK INC.
Application
ANDA206298
Marketing category
ANDA
Marketing start
2022-07-28
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
30 mg/g
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3464DICLOFENAC SODIUM GEL [REMEDYREPACK INC.]2Legacy NDC20240112_1719c635-4ccd-48c0-9614-bf3967a6a2ec.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3464-0705183464001 TUBE in 1 CARTON (70518-3464-0) > 100 g in 1 TUBE1 tube2022-07-280000-00-00NoNoCurrent