Search by Drug Name or NDC

NDC 53002-1338-03 Celecoxib 200 mg/1 Details

Celecoxib 200 mg/1

Celecoxib is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. The primary component is CELECOXIB.

MedlinePlus Drug Summary

Celecoxib is used to relieve pain, tenderness, swelling and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), and ankylosing spondylitis (arthritis that mainly affects the spine). Celecoxib is also used to treat juvenile rheumatoid arthritis (a type of arthritis that affects children) in children 2 years of age and older. Celecoxib is also used to treat painful menstrual periods and to relieve other types of short-term pain including pain caused by injuries, surgery and other medical or dental procedures, or medical conditions that last for a limited time. Celecoxib is in a class of NSAIDs called COX-2 inhibitors. It works by stopping the body's production of a substance that causes pain and inflammation.

Related Packages: 53002-1338-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Celecoxib

Product Information

NDC	53002-1338
Product ID	53002-1338_62397cb6-9faf-4461-8c12-89899d645a22
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	Celecoxib
Proprietary Name Suffix	n/a
Non-Proprietary Name	Celecoxib
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/1
Substance Name	CELECOXIB
Labeler Name	RPK Pharmaceuticals, Inc.
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA204519
Listing Certified Through	2024-12-31

Package

NDC 53002-1338-03 (53002133803)

Pricing Information	N/A
NDC Package Code	53002-1338-3
Billing NDC	53002133803
Package	30 CAPSULE in 1 BOTTLE (53002-1338-3)
Marketing Start Date	2018-10-01
NDC Exclude Flag	N