Prescription drug · ANDA
Celecoxib NDC 85509-1237
Celecoxib 100 mg/1 · Capsule · Oral · PHOENIX RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85509-1237-1 | 85509123701 | 120 CAPSULE in 1 BOTTLE (85509-1237-1)Marketed from Jul 21, 2025 | |
| 85509-1237-3 | 85509123703 | 30 CAPSULE in 1 BOTTLE (85509-1237-3)Marketed from Jul 21, 2025 | |
| 85509-1237-6 | 85509123706 | 60 CAPSULE in 1 BOTTLE (85509-1237-6)Marketed from Jul 21, 2025 | |
| 85509-1237-9 | 85509123709 | 90 CAPSULE in 1 BOTTLE (85509-1237-9)Marketed from Jul 21, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- PHOENIX RX LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210628
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 85509-1237_3b76876f-39e9-82e3-e063-6294a90afafeSPL ID 3b76876f-39e9-82e3-e063-6294a90afafeSPL set ID 3a669c28-fbc7-827c-e063-6394a90a0829RxCUI 205322UNII 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
N485509123701followed by a unit qualifier and the quantityPackage 85509-1237-01. 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)
1. INDICATIONS AND USAGE Celecoxib capsule are indicated Celecoxib capsules are 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210628
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 50 mg/1 | CapsuleOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-236 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-237 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-238 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-239 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0281 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3424 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2357 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2019 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Umedica Laboratories USA Inc. | 60290-017 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Umedica Laboratories USA Inc. | 60290-016 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Umedica Laboratories USA Inc. | 60290-018 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Umedica Laboratories USA Inc. | 60290-019 |