Prescription drug · ANDA
Celecoxib NDC 69097-420
Celecoxib 400 mg/1 · Capsule · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-420-02 | 69097042002 | 30 CAPSULE in 1 BOTTLE (69097-420-02)Marketed from Sep 23, 2015 | |
| 69097-420-03 | 69097042003 | 60 CAPSULE in 1 BOTTLE (69097-420-03)Marketed from Sep 23, 2015 | |
| 69097-420-11 | 69097042011 | 480 CAPSULE in 1 BOTTLE (69097-420-11)Marketed from Sep 23, 2015 | |
| 69097-420-21 | 69097042021 | 10 BLISTER PACK in 1 CARTON (69097-420-21) / 10 CAPSULE in 1 BLISTER PACK (69097-420-19)Marketed from Sep 23, 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 — 400 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207446
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 69097-420_8df39b9c-af70-4ac3-ba9f-6e8e795ba961SPL ID 8df39b9c-af70-4ac3-ba9f-6e8e795ba961SPL set ID d12625b1-2af9-4532-af91-d40b65eeffefRxCUI 205322, 205323, 349514, 686379UNII 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
N469097042002followed by a unit qualifier and the quantityPackage 69097-0420-02. 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 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 ) Celecoxib capsules are indicated 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207446
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 | NorthStar RxLLC | 16714-731 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Quallent Pharmaceuticals Health LLC | 82009-068 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | NorthStar RxLLC | 16714-732 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Quallent Pharmaceuticals Health LLC | 82009-069 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | NorthStar RxLLC | 16714-733 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | NorthStar RxLLC | 16714-734 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-059 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-060 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-301 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2233 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0039 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6759 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6758 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-669 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0142 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-421 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-422 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-423 |