Prescription drug · ANDA
Celecoxib NDC 80425-0281
Celecoxib 200 mg/1 · Capsule · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0281-1 | 80425028101 | 30 CAPSULE in 1 BOTTLE (80425-0281-1)Marketed from Mar 3, 2023 | |
| 80425-0281-2 | 80425028102 | 60 CAPSULE in 1 BOTTLE (80425-0281-2)Marketed from Mar 3, 2023 | |
| 80425-0281-3 | 80425028103 | 90 CAPSULE in 1 BOTTLE (80425-0281-3)Marketed from Mar 3, 2023 | |
| 80425-0281-4 | 80425028104 | 180 CAPSULE in 1 BOTTLE (80425-0281-4)Marketed from Mar 3, 2023 |
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 — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- 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 80425-0281_2a9ba8f4-6cea-e827-e063-6394a90a0300SPL ID 2a9ba8f4-6cea-e827-e063-6394a90a0300SPL set ID f60394f5-fd69-929b-e053-2995a90a5793RxCUI 205323UNII 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
N480425028101followed by a unit qualifier and the quantityPackage 80425-0281-01. 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 1.1 Osteoarthritis For the management of the signs and symptoms of OA [ see CLINICAL STUDIES (14.1)]. 1.2 Rheumatoid Arthritis For the management of the signs and symptoms of RA [ see CLINICAL STUDIES (14.2)]. 1.3 Juvenile Rheumatoid Arthritis For the management of the signs and symptoms of JRA in patients 2 years and older [ see CLINICAL STUDIES (14.3)]. 1.4 Ankylosing Spondylitis For the management of the signs and symptoms of AS [ see CLINICAL STUDIES (14.4)]. 1.5 Acute Pain For the management of acute pain in adults [ see CLINICAL STUDIES (14.5)]. 1.6 Primary Dysmenorrhea For the management of primary dysmenorrhea [ see CLINICAL ST…
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 100 mg/1 | CapsuleOral | PHOENIX RX LLC | 85509-1237 |
| 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 |