Prescription drug · ANDA
Celecoxib NDC 71209-055
Celecoxib 100 mg/1 · Capsule · Oral · Cadila Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71209-055-03 | 71209005503 | 60 CAPSULE in 1 BOTTLE (71209-055-03)Marketed from Aug 23, 2018 | |
| 71209-055-05 | 71209005505 | 100 CAPSULE in 1 BOTTLE (71209-055-05)Marketed from Sep 10, 2021 | |
| 71209-055-10 | 71209005510 | 500 CAPSULE in 1 BOTTLE (71209-055-10)Marketed from Sep 10, 2021 | |
| 71209-055-11 | 71209005511 | 1000 CAPSULE in 1 BOTTLE (71209-055-11)Marketed from Aug 23, 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208701
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 71209-055_491c8284-c565-4c6b-8d88-4373b179be4bSPL ID 491c8284-c565-4c6b-8d88-4373b179be4bSPL set ID 78ce3df5-07ee-43bb-9348-104a9524a032RxCUI 205322, 205323, 349514, 686379UNII JCX84Q7J1LUPC 0371209055055, 0371209054119, 0371209055109, 0371209056038, 0371209056106, 0371209054034, 0371209056052
- 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
N471209005503followed by a unit qualifier and the quantityPackage 71209-0055-03. 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 capsules are 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 [se…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208701
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 | Bryant Ranch Prepack | 72162-2421 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4009 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Modavar Pharmaceuticals LLC | 72241-024 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Modavar Pharmaceuticals LLC | 72241-022 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Modavar Pharmaceuticals LLC | 72241-023 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Modavar Pharmaceuticals LLC | 72241-025 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Cadila Pharmaceuticals Limited | 71209-056 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Cadila Pharmaceuticals Limited | 71209-054 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Cadila Pharmaceuticals Limited | 71209-057 |