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NDC 68788-8952-08 Diclofenac Sodium 50 mg/1 Details

Diclofenac Sodium 50 mg/1

Diclofenac Sodium is a ORAL TABLET, DELAYED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is DICLOFENAC SODIUM.

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: 68788-8952-08
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diclofenac

Product Information

NDC	68788-8952
Product ID	68788-8952_d7a8177e-1021-442e-8a9e-e2cc07a3d6a2
Associated GPIs	66100007200620
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 Sodium
Proprietary Name Suffix	Delayed Release
Non-Proprietary Name	Diclofenac Sodium
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, DELAYED RELEASE
Route	ORAL
Active Ingredient Strength	50
Active Ingredient Units	mg/1
Substance Name	DICLOFENAC SODIUM
Labeler Name	Preferred 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	ANDA075185
Listing Certified Through	2024-12-31

Package

NDC 68788-8952-08 (68788895208)

Pricing Information	N/A
NDC Package Code	68788-8952-8
Billing NDC	68788895208
Package	120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-8952-8)
Marketing Start Date	2015-11-20
NDC Exclude Flag	N