Diclofenac Potassium

Product NDC
82804-010
11-digit product format
828040010
Labeler code
82804
Product ID
82804-010_94586867-c75b-4d60-be1d-03a9e4b7cd10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075229
Marketing category
ANDA
Marketing start
2020-12-19
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
82804-010-308280400103030 TABLET, COATED in 1 BOTTLE (82804-010-30) 2023-09-13NoNoHistorical
82804-010-608280400106060 TABLET, COATED in 1 BOTTLE (82804-010-60) 2023-09-13NoNoHistorical
82804-010-908280400109090 TABLET, COATED in 1 BOTTLE (82804-010-90) 2023-09-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diclofenac Potassium Tablets, USP 50 mgProficient Rx LP2023-09-01HUMAN PRESCRIPTION DRUG LABEL1