Prescription drug · ANDA
Celecoxib NDC 80425-0382
Celecoxib 200 mg/1 · Capsule · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0382-1 | 80425038201 | 30 CAPSULE in 1 BOTTLE (80425-0382-1)Marketed from Apr 10, 2024 | |
| 80425-0382-2 | 80425038202 | 60 CAPSULE in 1 BOTTLE (80425-0382-2)Marketed from Apr 10, 2024 | |
| 80425-0382-3 | 80425038203 | 90 CAPSULE in 1 BOTTLE (80425-0382-3)Marketed from Apr 10, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Celecoxib
- Generic name (nonproprietary)
- celecoxib
- Active ingredients
- Celecoxib — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205129
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0382_15d6dd95-80ed-a392-e063-6394a90a8770SPL ID 15d6dd95-80ed-a392-e063-6394a90a8770SPL set ID 15d6ef4f-568d-9d3e-e063-6294a90ab04cRxCUI 205323UNII JCX84Q7J1L
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480425038201followed by a unit qualifier and the quantityPackage 80425-0382-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
1. INDICATIONS AND USAGE Celecoxib is indicated Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis (RA) ( 1.2 ) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Acute Pain (AP) ( 1.5 ) Primary Dysmenorrhea (PD) ( 1.6 ) 1.1 Osteoarthritis(OA) For the management of the signs and symptoms of OA [ see Clinical Studies (14.1) ] 1.2 Rheumatoid Arthritis (RA) For the management of the signs and symptoms of RA [ see Clinical Studies (14.2) ] 1.3 Juvenile Rheumatoid Arthritis (JRA) For the management of the signs and symptoms of JRA in patients 2 years and older [ see Clinical …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205129
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-649 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3733 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Sportpharm LLC | 85766-009 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Medsource Pharmaceuticals | 45865-234 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc. | 50228-157 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc. | 50228-156 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc. | 50228-158 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc. | 50228-159 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | St Mary's Medical Park Pharmacy | 60760-742 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Proficient Rx LP | 71205-664 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-8197 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-584 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2254 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | PHOENIX RX LLC | 85509-1158 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-8206 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2220 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2222 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Quality Care Products, LLC | 83008-013 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4619 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-843 |
Showing 20 of 35.