Prescription drug · ANDA
Celecoxib NDC 70247-008
Celecoxib 200 mg/1 · Capsule · Oral · Qingdao BAHEAL Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70247-008-10 | 70247000810 | 100 CAPSULE in 1 BOTTLE (70247-008-10)Marketed from Oct 10, 2016 | |
| 70247-008-50 | 70247000850 | 500 CAPSULE in 1 BOTTLE (70247-008-50)Marketed from Oct 10, 2016 |
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 — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208856
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 70247-008_484ff9da-73fb-fd59-e063-6294a90a257fSPL ID 484ff9da-73fb-fd59-e063-6294a90a257fSPL set ID 87c16a33-5eb0-40b0-a020-ed924326f697RxCUI 205322, 205323, 349514, 686379UNII JCX84Q7J1LUPC 0370247006067, 0370247008504, 0370247008108, 0370247007507, 0370247007101, 0370247009068
- 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
N470247000810followed by a unit qualifier and the quantityPackage 70247-0008-10. 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 are indicated 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) 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 208856
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 | AiPing Pharmaceutical, Inc. | 11788-115 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | AiPing Pharmaceutical, Inc. | 11788-112 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | AiPing Pharmaceutical, Inc. | 11788-113 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | AiPing Pharmaceutical, Inc. | 11788-114 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-942 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Qingdao BAHEAL Pharmaceutical Co., Ltd. | 70247-006 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Qingdao BAHEAL Pharmaceutical Co., Ltd. | 70247-007 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Qingdao BAHEAL Pharmaceutical Co., Ltd. | 70247-009 |