Prescription drug · ANDA
Celecoxib NDC 82804-213
Celecoxib 200 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-213-14 | 8280402131482804021314 | 14 CAPSULE in 1 BOTTLE (82804-213-14)Marketed from Jun 26, 2025 | |
| 82804-213-30 | 8280402133082804021330 | 30 CAPSULE in 1 BOTTLE (82804-213-30)Marketed from Apr 3, 2025 | |
| 82804-213-60 | 8280402136082804021360 | 60 CAPSULE in 1 BOTTLE (82804-213-60)Marketed from Apr 21, 2025 | |
| 82804-213-90 | 8280402139082804021390 | 90 CAPSULE in 1 BOTTLE (82804-213-90)Marketed from May 2, 2025 |
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
- Labeler
- Proficient Rx LPNDC labeler code 82804
- 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 82804-213_2708ae7f-53a6-478d-bf2e-e4f43e6bb323SPL ID 2708ae7f-53a6-478d-bf2e-e4f43e6bb323SPL set ID 3a450db8-313c-4120-9b8e-58c956323fa4RxCUI 205323UNII JCX84Q7J1LUPC 0382804213306
- 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
N482804021314followed by a unit qualifier and the quantityPackage 82804-0213-14. 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 is indicated Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: • Osteoarthritis (OA) ( Error! Hyperlink reference not valid. ) • Rheumatoid Arthritis (RA) ( Error! Hyperlink reference not valid. ) • Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( Error! Hyperlink reference not valid. ) • Ankylosing Spondylitis (AS) ( Error! Hyperlink reference not valid. ) • Acute Pain (AP) ( Error! Hyperlink reference not valid. ) • Primary Dysmenorrhea (PD) ( Error! Hyperlink reference not valid. ) 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA [ see Error! Hyperlink reference not valid. ]. 1.2 Rheumatoid Art…
Excerpt only. Read the full label for complete information.
About NDC 82804-213
- What is NDC 82804-213?
- 82804-213 is the product NDC for Celecoxib, Celecoxib 200 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Celecoxib.
- What is the active ingredient?
- Celecoxib.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Celecoxib?
- 230 other product NDCs are listed under this name. See all Celecoxib NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Celecoxib products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Direct_Rx | 72189-695 | 72189-0695-3072189-0695-60 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-942 | 60760-0942-60 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Direct_Rx | 72189-685 | 72189-0685-6072189-0685-72 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4726 | 70518-4726-00 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-958 | 60760-0958-1560760-0958-3060760-0958-60 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0160 | 55154-0160-00 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4619 | 70518-4619-00 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7550 | 00904-7550-61 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7551 | 00904-7551-61 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Avet Pharmaceuticals Inc. | 23155-964 | 23155-0964-0123155-0964-05 |
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 50 mg/1 | CapsuleOral | Cranbury Pharmaceuticals, LLC | 27808-295 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Cranbury Pharmaceuticals, LLC | 27808-296 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Cranbury Pharmaceuticals, LLC | 27808-297 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6577 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7072 |
| 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 200 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-958 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-995 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-996 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Redpharm Drug | 67296-2236 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3642 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Preferred Pharmaceutical Inc. | 68788-4095 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8679 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-301 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-302 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3826 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4175 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4508 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2456 |
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