Prescription drug · ANDA
Celecoxib NDC 62135-021
Celecoxib 100 mg/1 · Capsule · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-021-60 | 62135002160 | 60 CAPSULE in 1 BOTTLE (62135-021-60)Marketed from Aug 22, 2022 |
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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211412
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 62135-021_459b4316-89e1-0bb1-e063-6294a90a518dSPL ID 459b4316-89e1-0bb1-e063-6294a90a518dSPL set ID a99a67f3-ccaa-4d54-8922-d6dd30fba274RxCUI 205322, 205323, 349514UNII JCX84Q7J1LUPC 0362135021603, 0362135022600, 0362135023607, 0362135022013
- 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
N462135002160followed by a unit qualifier and the quantityPackage 62135-0021-60. 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)
1. INDICATIONS AND USAGE Celecoxib capsules are indicated Celecoxib capsule is a nonsteroidal anti-inflammatory drug indicated for: ( 1 ) 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 ye…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211412
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 400 mg/1 | CapsuleOral | Yiling Pharmaceutical, Inc. | 69117-0023 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-022 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-023 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Avet Pharmaceuticals Inc. | 23155-963 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Avet Pharmaceuticals Inc. | 23155-964 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Avet Pharmaceuticals Inc. | 23155-965 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Avet Pharmaceuticals Inc. | 23155-966 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Yiling Pharmaceutical, Inc. | 69117-0022 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Yiling Pharmaceutical, Inc. | 69117-0020 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Yiling Pharmaceutical, Inc. | 69117-0021 |