Diclofenac sodium

Product NDC
70518-4044
11-digit product format
705184044
Labeler code
70518
Product ID
70518-4044_377909b0-0bfd-8e16-e063-6394a90a5f5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA216275
Marketing category
ANDA
Marketing start
2024-04-05
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
QTG126297QDICLOFENAC SODIUM15307-79-6DICLOFENAC SODIUM

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4044-07051840440060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4044-0) 2024-04-05NoNoHistorical
70518-4044-17051840440130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4044-1) 2025-06-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diclofenac sodiumREMEDYREPACK INC.2025-06-13HUMAN PRESCRIPTION DRUG LABEL4