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NDC 33342-0158-12 celecoxib 400 mg/1 Details
celecoxib 400 mg/1
celecoxib is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Macleods Pharmaceuticals Limited. 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: 33342-0158-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Celecoxib
Product Information
| NDC | 33342-0158 |
|---|---|
| Product ID | 33342-158_ee4b91b0-3525-4a94-b0ed-fd694ed1154c |
| Associated GPIs | 66100525000140 |
| GCN Sequence Number | 050832 |
| GCN Sequence Number Description | celecoxib CAPSULE 400 MG ORAL |
| HIC3 | S2L |
| HIC3 Description | NSAIDS,CYCLOOXYGENASE-2(COX-2) SELECTIVE INHIBITOR |
| GCN | 18127 |
| HICL Sequence Number | 018979 |
| HICL Sequence Number Description | CELECOXIB |
| Brand/Generic | Generic |
| 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 | 400 |
| Active Ingredient Units | mg/1 |
| Substance Name | CELECOXIB |
| Labeler Name | Macleods Pharmaceuticals Limited |
| 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 | ANDA204590 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 33342-0158-12 (33342015812)
| NDC Package Code | 33342-158-12 |
|---|---|
| Billing NDC | 33342015812 |
| Package | 10 BLISTER PACK in 1 CARTON (33342-158-12) / 10 CAPSULE in 1 BLISTER PACK |
| Marketing Start Date | 2016-03-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |