Prescription drug · ANDA
Celecoxib NDC 68788-4095
Celecoxib 100 mg/1 · Capsule · Oral · Preferred Pharmaceutical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-4095-3 | 68788409503 | 30 CAPSULE in 1 BOTTLE (68788-4095-3)Marketed from Mar 18, 2026 | |
| 68788-4095-6 | 68788409506 | 60 CAPSULE in 1 BOTTLE (68788-4095-6)Marketed from Mar 18, 2026 | |
| 68788-4095-9 | 68788409509 | 90 CAPSULE in 1 BOTTLE (68788-4095-9)Marketed from Mar 18, 2026 |
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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210071
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 68788-4095_7f20976d-bed3-4a06-9aaf-f5b5240e4ce3SPL ID 7f20976d-bed3-4a06-9aaf-f5b5240e4ce3SPL set ID 7f20976d-bed3-4a06-9aaf-f5b5240e4ce3RxCUI 205322UNII 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
N468788409503followed by a unit qualifier and the quantityPackage 68788-4095-03. 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 is 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 [see Clinical Studies (14…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210071
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 | Mullan Pharmaceutical Inc. | 83301-0011 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Mullan Pharmaceutical Inc. | 83301-0012 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Direct_Rx | 72189-662 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Mullan Pharmaceutical Inc. | 83301-0028 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0209 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7072 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3826 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3642 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-582 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4508 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-034 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2456 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Proficient Rx LP | 82804-213 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Redpharm Drug | 67296-2236 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-8031 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-8036 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0321 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Direct_Rx | 72189-685 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6577 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8679 |
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