Prescription drug · ANDA
Celecoxib NDC 63187-562
Celecoxib 200 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-562-15 | 6318705621563187056215 | 15 CAPSULE in 1 BOTTLE (63187-562-15)Marketed from Dec 1, 2018 | |
| 63187-562-30 | 6318705623063187056230 | 30 CAPSULE in 1 BOTTLE (63187-562-30)Marketed from Dec 1, 2018 | |
| 63187-562-60 | 6318705626063187056260 | 60 CAPSULE in 1 BOTTLE (63187-562-60)Marketed from Dec 1, 2018 | |
| 63187-562-90 | 6318705629063187056290 | 90 CAPSULE in 1 BOTTLE (63187-562-90)Marketed from Dec 1, 2018 |
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
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204197
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 63187-562_94327867-b615-4077-85a8-b7647355169bSPL ID 94327867-b615-4077-85a8-b7647355169bSPL set ID 6dd743d3-4821-4919-90eb-6d306ca7999fRxCUI 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
N463187056215followed by a unit qualifier and the quantityPackage 63187-0562-15. 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 Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ] 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) Celecoxib capsules are indicated for relief of the signs and sy…
Excerpt only. Read the full label for complete information.
About NDC 63187-562
- What is NDC 63187-562?
- 63187-562 is the product NDC for Celecoxib, Celecoxib 200 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Celecoxib.
- What is the active ingredient?
- Celecoxib.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Celecoxib?
- 230 other product NDCs are listed under this name. See all Celecoxib NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Celecoxib products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Direct_Rx | 72189-695 | 72189-0695-3072189-0695-60 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-942 | 60760-0942-60 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Direct_Rx | 72189-685 | 72189-0685-6072189-0685-72 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4726 | 70518-4726-00 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-958 | 60760-0958-1560760-0958-3060760-0958-60 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0160 | 55154-0160-00 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4619 | 70518-4619-00 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7550 | 00904-7550-61 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7551 | 00904-7551-61 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Avet Pharmaceuticals Inc. | 23155-964 | 23155-0964-0123155-0964-05 |
Other NDCs under ANDA 204197
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 200 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-825 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5178 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Apotex Corp. | 60505-3848 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Apotex Corp. | 60505-3849 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0292 |