Prescription drug · ANDA
Celecoxib NDC 46708-269
Celecoxib 200 mg/1 · Capsule · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-269-12 | 46708026912 | 80 CAPSULE in 1 CARTON (46708-269-12)Marketed from Aug 22, 2015 | |
| 46708-269-30 | 46708026930 | 30 CAPSULE in 1 BOTTLE (46708-269-30)Marketed from Aug 22, 2015 | |
| 46708-269-31 | 46708026931 | 100 CAPSULE in 1 BOTTLE (46708-269-31)Marketed from Aug 22, 2015 | |
| 46708-269-60 | 46708026960 | 60 CAPSULE in 1 BOTTLE (46708-269-60)Marketed from Aug 22, 2015 | |
| 46708-269-71 | 46708026971 | 500 CAPSULE in 1 BOTTLE (46708-269-71)Marketed from Aug 22, 2015 | |
| 46708-269-91 | 46708026991 | 1000 CAPSULE in 1 BOTTLE (46708-269-91)Marketed from Aug 22, 2015 |
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
- 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 46708-269_c884ffd4-3a40-48a1-99b6-73b1ef9324b4SPL ID c884ffd4-3a40-48a1-99b6-73b1ef9324b4SPL set ID 14e8d788-e44c-4a40-8678-25cf45fed477RxCUI 205322, 205323, 349514, 686379UNII JCX84Q7J1LUPC 0346708267308, 0346708268305, 0346708269302, 0346708270308
- 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
N446708026912followed by a unit qualifier and the quantityPackage 46708-0269-12. 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)
Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ] Celecoxib is a non steroidal 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) Celecoxib is indicated for relief of the signs and symptoms of OA [ see Clinical Studies (14.1) ] 1.2 Rheumatoid Arthriti…
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 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 | Major Pharmaceuticals | 0904-7551 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | RedPharm Drug | 67296-1920 |
| Celecoxib 200 mgcelecoxib | Celecoxib 200 mg/1 | CapsuleOral | Proficient Rx LP | 63187-633 |