Prescription drug · ANDA
Celecoxib 200 mg (celecoxib) NDC 63187-633
Celecoxib 200 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-633-30 | 63187063330 | 30 CAPSULE in 1 BOTTLE (63187-633-30)Marketed from Nov 24, 2015 | |
| 63187-633-60 | 63187063360 | 60 CAPSULE in 1 BOTTLE (63187-633-60)Marketed from Nov 24, 2015 | |
| 63187-633-90 | 63187063390 | 90 CAPSULE in 1 BOTTLE (63187-633-90)Marketed from Nov 24, 2015 |
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 200 mg
- Generic name (nonproprietary)
- celecoxib
- Active ingredients
- Celecoxib — 200 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 204519
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 63187-633_a97c2b4d-4a9b-4343-be08-aff7778679ddSPL ID a97c2b4d-4a9b-4343-be08-aff7778679ddSPL set ID feee6a01-63f9-42c3-8bd8-ca713a08b36dRxCUI 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
N463187063330followed by a unit qualifier and the quantityPackage 63187-0633-30. 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. 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)R • heumatoid 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 is inCelecoxib is indicated for relief of the signs and symptoms of OA [see …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204519
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 | Proficient Rx LP | 71205-020 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-142 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-140 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-141 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-143 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Proficient Rx LP | 71205-055 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-268 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-267 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-269 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-270 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0160 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | AvPAK | 50268-168 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | AvPAK | 50268-169 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7550 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7551 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | RedPharm Drug | 67296-1920 |