Prescription drug · ANDA
Celecoxib NDC 76420-727
Celecoxib 100 mg/1 · Capsule · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-727-01 | 76420072701 | 1 CAPSULE in 1 BOTTLE (76420-727-01)Marketed from May 10, 2024 | |
| 76420-727-05 | 76420072705 | 500 CAPSULE in 1 BOTTLE (76420-727-05)Marketed from May 10, 2024 | |
| 76420-727-07 | 76420072707 | 7 CAPSULE in 1 BOTTLE (76420-727-07)Marketed from May 10, 2024 | |
| 76420-727-10 | 76420072710 | 100 CAPSULE in 1 BOTTLE (76420-727-10)Marketed from May 10, 2024 | |
| 76420-727-14 | 76420072714 | 14 CAPSULE in 1 BOTTLE (76420-727-14)Marketed from May 10, 2024 | |
| 76420-727-20 | 76420072720 | 20 CAPSULE in 1 BOTTLE (76420-727-20)Marketed from May 10, 2024 | |
| 76420-727-30 | 76420072730 | 30 CAPSULE in 1 BOTTLE (76420-727-30)Marketed from May 10, 2024 | |
| 76420-727-60 | 76420072760 | 60 CAPSULE in 1 BOTTLE (76420-727-60)Marketed from May 10, 2024 | |
| 76420-727-90 | 76420072790 | 90 CAPSULE in 1 BOTTLE (76420-727-90)Marketed from May 10, 2024 |
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
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200562
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 76420-727_1814718c-03dc-471b-e063-6394a90a880eSPL ID 1814718c-03dc-471b-e063-6394a90a880eSPL set ID 265b50cc-6d99-4ef8-8439-6792e1f21c68RxCUI 205322, 205323, 349514, 686379UNII 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
N476420072701followed by a unit qualifier and the quantityPackage 76420-0727-01. 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 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 [see Clinical Stu…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200562
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 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-643 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-714 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-726 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 0591-3982 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-728 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 0591-3983 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 0591-3984 |