Prescription drug · ANDA
celecoxib NDC 13668-307
Celecoxib 50 mg/1 · Capsule · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-307-01 | 13668030701 | 100 CAPSULE in 1 BOTTLE (13668-307-01)Marketed from Dec 23, 2015 | |
| 13668-307-05 | 13668030705 | 500 CAPSULE in 1 BOTTLE (13668-307-05)Marketed from Dec 23, 2015 | |
| 13668-307-10 | 13668030710 | 1000 CAPSULE in 1 BOTTLE (13668-307-10)Marketed from Dec 23, 2015 | |
| 13668-307-30 | 13668030730 | 30 CAPSULE in 1 BOTTLE (13668-307-30)Marketed from Dec 23, 2015 | |
| 13668-307-31 | 13668030731 | 2500 CAPSULE in 1 BOTTLE (13668-307-31)Marketed from Dec 23, 2015 | |
| 13668-307-60 | 13668030760 | 60 CAPSULE in 1 BOTTLE (13668-307-60)Marketed from Dec 23, 2015 | |
| 13668-307-90 | 13668030790 | 90 CAPSULE in 1 BOTTLE (13668-307-90)Marketed from Dec 23, 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
- Generic name (nonproprietary)
- celecoxib
- Active ingredients
- Celecoxib — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207677
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 13668-307_bff3a32b-43e3-46cd-b5c3-b691617fe4faSPL ID bff3a32b-43e3-46cd-b5c3-b691617fe4faSPL set ID 862698b6-2cc9-4374-992d-024beae6eba3RxCUI 205322, 205323, 349514, 686379UNII JCX84Q7J1LUPC 0313668441307, 0313668307306, 0313668310306
- 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
N413668030701followed by a unit qualifier and the quantityPackage 13668-0307-01. 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 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 ) Celecoxib is indicated 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207677
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 | Torrent Pharmaceuticals Limited | 13668-310 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-442 |
| celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-441 |