Prescription drug · ANDA
Celecoxib NDC 65862-907
Celecoxib 50 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-907-60 | 65862090760 | 60 CAPSULE in 1 BOTTLE (65862-907-60)Marketed from Feb 1, 2016 | |
| 65862-907-99 | 65862090799 | 1000 CAPSULE in 1 BOTTLE (65862-907-99)Marketed from Feb 1, 2016 |
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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206827
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-907_5969bc02-84f8-41e5-a6b5-abcb6a985591SPL ID 5969bc02-84f8-41e5-a6b5-abcb6a985591SPL set ID 1e811c3a-5653-4617-b958-380802cc443aRxCUI 205322, 205323, 349514, 686379UNII 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
N465862090760followed by a unit qualifier and the quantityPackage 65862-0907-60. 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)
Celecoxib capsules are 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 (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 Clinical Studies (14.3) ]. 1.4 Ankyl…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206827
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 | REMEDYREPACK INC. | 70518-4726 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8571 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8572 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-909 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-908 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-910 |