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NDC 53002-1176-03 Diclofenac Potassium 50 mg/1 Details

Diclofenac Potassium 50 mg/1

Diclofenac Potassium is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. The primary component is DICLOFENAC POTASSIUM.

MedlinePlus Drug Summary

Diclofenac capsules (Zipsor, Zorvolex) and tablets (Cataflam) are used to relieve mild to moderate pain. Diclofenac extended-release tablets (Voltaren XR), tablets (Cataflam), and delayed-release tablets (available generically) are used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Diclofenac extended-release tablets and delayed-release tablets are also used to treat ankylosing spondylitis (arthritis that mainly affects the spine). Diclofenac tablets (Cataflam) are also used to treat painful menstrual periods. Diclofenac solution (Cambia) is used to treat migraine headaches in adults, but cannot be used to prevent migraines or to treat other types of headaches. Diclofenac is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Related Packages: 53002-1176-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diclofenac

Product Information

NDC	53002-1176
Product ID	53002-1176_e5e1b3b3-dad6-49d6-b7e3-d04726857102
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Diclofenac Potassium
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diclofenac Potassium
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/1
Substance Name	DICLOFENAC POTASSIUM
Labeler Name	RPK Pharmaceuticals, Inc.
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075219
Listing Certified Through	2024-12-31

Package

NDC 53002-1176-03 (53002117603)

Pricing Information	N/A
NDC Package Code	53002-1176-3
Billing NDC	53002117603
Package	30 TABLET, FILM COATED in 1 BOTTLE (53002-1176-3)
Marketing Start Date	2018-10-01
NDC Exclude Flag	N