Diclofenac Sodium

Product NDC
70518-1903
11-digit product format
705181903
Labeler code
70518
Product ID
70518-1903_ea73a528-3070-6e76-e053-2995a90a9faa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076201
Marketing category
ANDA
Marketing start
2019-02-25
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
100 mg/1
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-1903-0EA - Each70518-1903e8ccc56f-81f0-4bed-90ed-1a6a7ecf045812024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1903DICLOFENAC SODIUM TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]8Legacy NDC20250302_51635427-fb13-45ee-813d-a40b0405d14f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1903-07051819030030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-1903-0) 2019-02-250000-00-00NoNoCurrent
70518-1903-17051819030160 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-1903-1) 2021-03-170000-00-00NoNoCurrent