Prescription drug · ANDA
Celecoxib NDC 63187-643
Celecoxib 100 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-643-30 | 63187064330 | 30 CAPSULE in 1 BOTTLE (63187-643-30)Marketed from Dec 1, 2018 | |
| 63187-643-60 | 63187064360 | 60 CAPSULE in 1 BOTTLE (63187-643-60)Marketed from Dec 1, 2018 | |
| 63187-643-90 | 63187064390 | 90 CAPSULE in 1 BOTTLE (63187-643-90)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 — 100 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 200562
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 63187-643_87d8cb44-f135-4660-8988-ad81480a9308SPL ID 87d8cb44-f135-4660-8988-ad81480a9308SPL set ID c529b321-38ed-434f-b76e-06902cdd40dcRxCUI 205322UNII JCX84Q7J1LUPC 0363187643607
- 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
N463187064330followed by a unit qualifier and the quantityPackage 63187-0643-30. 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 capsules 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 is indicated for relief of the signs and symp…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200562
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 | Asclemed USA, Inc. | 76420-714 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-726 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 0591-3982 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-727 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-728 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 0591-3983 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 0591-3984 |