Diclofenac Sodium

Product NDC
70518-2673
11-digit product format
705182673
Labeler code
70518
Product ID
70518-2673_d6e40617-1105-4cdf-e053-2995a90a436f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
GEL
Route
TOPICAL
Labeler
REMEDYREPACK INC.
Application
ANDA209484
Marketing category
ANDA
Marketing start
2020-04-07
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
10 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2673-0GM - Gram70518-2673f95fa1a1-2fc2-4a47-b47b-7e99b6c6ec8f12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2673DICLOFENAC SODIUM GEL [REMEDYREPACK INC.]4Legacy NDC20220201_35f52a3c-6e79-40c1-91db-0db4335b20d9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2673-0705182673001 TUBE in 1 CARTON (70518-2673-0) > 100 g in 1 TUBE1 tube2020-04-070000-00-00NoNoCurrent