Prescription drug · ANDA
Celecoxib NDC 57582-212
Celecoxib 100 mg/1 · Capsule · Oral · Tianjin Tianyao Pharmaceuticals Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57582-212-01 | 57582021201 | 100 CAPSULE in 1 BOTTLE (57582-212-01)Marketed from Feb 25, 2020 | |
| 57582-212-02 | 57582021202 | 500 CAPSULE in 1 BOTTLE (57582-212-02)Marketed from Feb 25, 2020 | |
| 57582-212-03 | 57582021203 | 100 CAPSULE in 1 CARTON (57582-212-03)Marketed from Feb 25, 2020 |
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 207872
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 57582-212_30949e07-504d-43c2-b0d1-1c26dcaed176SPL ID 30949e07-504d-43c2-b0d1-1c26dcaed176SPL set ID 76f9bcb7-0e94-485f-816d-61d4e1ed24e0RxCUI 205322, 205323, 349514, 686379UNII JCX84Q7J1LUPC 0357582214029, 0357582213015, 0357582213039, 0357582212018, 0357582211011, 0357582214012, 0357582213022, 0357582212032, 0357582212025
- 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
N457582021201followed by a unit qualifier and the quantityPackage 57582-0212-01. 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 capsules is indicated Celecoxib capsules 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) 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 an…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207872
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 | EPIC PHARMA, LLC | 42806-722 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | EPIC PHARMA, LLC | 42806-720 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | EPIC PHARMA, LLC | 42806-721 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Tianjin Tianyao Pharmaceuticals Co., Ltd. | 57582-211 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | EPIC PHARMA, LLC | 42806-723 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Tianjin Tianyao Pharmaceuticals Co., Ltd. | 57582-213 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Tianjin Tianyao Pharmaceuticals Co., Ltd. | 57582-214 |