Prescription drug · ANDA
celecoxib NDC 43063-967
Celecoxib 200 mg/1 · Capsule · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-967-14 | 43063096714 | 14 CAPSULE in 1 BOTTLE, PLASTIC (43063-967-14)Marketed from May 11, 2020 | |
| 43063-967-30 | 43063096730 | 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-967-30)Marketed from Apr 5, 2019 | |
| 43063-967-60 | 43063096760 | 60 CAPSULE in 1 BOTTLE, PLASTIC (43063-967-60)Marketed from Mar 27, 2019 |
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 — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- 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 43063-967_53c5024c-a09e-2904-e063-6294a90a8d3fSPL ID 53c5024c-a09e-2904-e063-6294a90a8d3fSPL set ID 78d59905-4a78-4d9f-ac29-58790a5b3a92RxCUI 205323UNII JCX84Q7J1LUPC 0343063967300
- 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
N443063096714followed by a unit qualifier and the quantityPackage 43063-0967-14. 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)
Celecoxib capsules are indicated Celecoxib capsules are 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 …
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 | 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 200 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0096 |
| celecoxib | Celecoxib 100 mg/1 | CapsuleOral | HAWAII REPACK, INC. | 85534-0014 |
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