Diclofenac Potassium

Product NDC
68071-3451
11-digit product format
680713451
Labeler code
68071
Product ID
68071-3451_2d68439e-17d1-b835-e063-6294a90a4737
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Potassium Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA215750
Marketing category
ANDA
Marketing start
2022-05-12
Substance
DICLOFENAC POTASSIUM
Active strength
50 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
L4D5UA6CB4DICLOFENAC POTASSIUM15307-81-0DICLOFENAC POTASSIUM

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3451-36807134510330 TABLET, FILM COATED in 1 BOTTLE (68071-3451-3) 2023-07-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diclofenac Potassium TabletsNuCare Pharmaceuticals,Inc.2025-02-05HUMAN PRESCRIPTION DRUG LABEL3