Prescription drug · ANDA
Celecoxib NDC 82804-151
Celecoxib 100 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-151-60 | 82804015160 | 60 CAPSULE in 1 BOTTLE (82804-151-60)Marketed from Sep 24, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204776
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 82804-151_1071fcb5-0e9f-4e30-8fb4-df76fd876fe8SPL ID 1071fcb5-0e9f-4e30-8fb4-df76fd876fe8SPL set ID 1071fcb5-0e9f-4e30-8fb4-df76fd876fe8RxCUI 205322UNII JCX84Q7J1LUPC 0382804151608
- 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
N482804015160followed by a unit qualifier and the quantityPackage 82804-0151-60. 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 For the management of the signs and symptoms of OA [ see Clinical Studies (14.1) ]. 1.2 Rheumatoid Arthritis For the management of the signs and symptoms of RA [ see Clinical Studies (14.2) ]. 1.3 Juvenile Rheumatoid Arthritis For the management of the signs and symptoms of JRA in patients 2 years and older [ see Clinical S…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204776
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 | Bryant Ranch Prepack | 71335-1804 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6380 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1066 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-4789 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0040 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Micro Labs Limited | 42571-142 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Micro Labs Limited | 42571-143 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Micro Labs Limited | 42571-144 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Micro Labs Limited | 42571-145 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2380 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | American Health Packaging | 60687-436 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-436 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-437 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | American Health Packaging | 60687-447 |