Prescription drug · ANDA
Celecoxib NDC 0904-7551
Celecoxib 200 mg/1 · Capsule · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7551-61 | 00904755161 | 100 BLISTER PACK in 1 CARTON (0904-7551-61) / 1 CAPSULE in 1 BLISTER PACKMarketed from Apr 6, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204519
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 0904-7551_4c165daf-efed-4c93-9add-e81a4523946dSPL ID 4c165daf-efed-4c93-9add-e81a4523946dSPL set ID 3a1eadd5-c0a7-473e-bde0-6b9450d11c95RxCUI 205322, 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
N400904755161followed by a unit qualifier and the quantityPackage 00904-7551-61. 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 (14.3…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204519
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 | 71205-020 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-142 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-140 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-141 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-143 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Proficient Rx LP | 71205-055 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-268 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-267 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-269 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-270 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0160 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | AvPAK | 50268-168 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | AvPAK | 50268-169 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7550 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | RedPharm Drug | 67296-1920 |
| Celecoxib 200 mgcelecoxib | Celecoxib 200 mg/1 | CapsuleOral | Proficient Rx LP | 63187-633 |