Prescription drug · ANDA
Celecoxib NDC 80425-0096
Celecoxib 200 mg/1 · Capsule · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0096-1 | 80425009601 | 30 CAPSULE in 1 BOTTLE (80425-0096-1)Marketed from Mar 16, 2016 | |
| 80425-0096-2 | 80425009602 | 60 CAPSULE in 1 BOTTLE (80425-0096-2)Marketed from Mar 16, 2016 | |
| 80425-0096-3 | 80425009603 | 90 CAPSULE in 1 BOTTLE (80425-0096-3)Marketed from Mar 16, 2016 |
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 204590
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0096_2a998d83-7baa-3f5e-e063-6294a90acd3dSPL ID 2a998d83-7baa-3f5e-e063-6294a90acd3dSPL set ID b3545cfb-97c3-b896-e053-2a95a90a15a0RxCUI 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
N480425009601followed by a unit qualifier and the quantityPackage 80425-0096-01. 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 .
Indications (excerpt from the label)
1. Indications and Usage Section 1 INDICATIONS AND USAGE Celecoxib capsules are indicated 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 Studies (14.3)] 1.4 Ankylosing Spondylitis For the management of the signs and symptoms of AS [see Clinical Studies (14.4)] 1.5 Acute Pain For the management of acute pain in adults [see Clinical Studies (14.5)] 1.6 Primary Dysmenorrhea For the management of primary dysmeno…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204590
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 | Direct Rx | 72189-123 |
| celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0936 |
| celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-243 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Proficient Rx LP | 71205-027 |
| celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Sportpharm LLC | 85766-030 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2489 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-7264 |
| celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-7286 |
| celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-155 |
| celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-156 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-157 |
| celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-158 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-967 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-009 |
| celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-439 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0037 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-253 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0323 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | RedPharm Drug, Inc. | 67296-1399 |
| celecoxib | Celecoxib 100 mg/1 | CapsuleOral | HAWAII REPACK, INC. | 85534-0014 |
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