Prescription drug · ANDA
Celecoxib NDC 69117-0021
Celecoxib 100 mg/1 · Capsule · Oral · Yiling Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69117-0021-1 | 6911700210169117002101 | 60 CAPSULE in 1 BOTTLE (69117-0021-1)Marketed from Mar 6, 2020 | |
| 69117-0021-2 | 6911700210269117002102 | 100 CAPSULE in 1 BOTTLE (69117-0021-2)Marketed from Mar 6, 2020 | |
| 69117-0021-3 | 6911700210369117002103 | 500 CAPSULE in 1 BOTTLE (69117-0021-3)Marketed from Mar 6, 2020 |
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
- Labeler
- Yiling Pharmaceutical, Inc.NDC labeler code 69117
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211412
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 69117-0021_4723852e-6cb6-442b-e063-6294a90a1b80SPL ID 4723852e-6cb6-442b-e063-6294a90a1b80SPL set ID 43979279-867b-4303-8f30-fc58ae75a069RxCUI 205322, 205323, 349514, 686379UNII JCX84Q7J1LUPC 0369117002230, 0369117002117, 0369117002223, 0369117002124, 0369117002315, 0369117002322, 0369117002018, 0369117002025, 0369117002216, 0369117002032, 0369117002339, 0369117002131
- 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
N469117002101followed by a unit qualifier and the quantityPackage 69117-0021-01. 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 capsules are indicated Celecoxib capsule 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 Cl…
Excerpt only. Read the full label for complete information.
About NDC 69117-0021
- What is NDC 69117-0021?
- 69117-0021 is the product NDC for Celecoxib, Celecoxib 100 mg/1 capsule, listed with the FDA by Yiling Pharmaceutical, Inc.. It has 3 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?
- Yiling Pharmaceutical, Inc., NDC labeler code 69117. 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 211412
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 | Yiling Pharmaceutical, Inc. | 69117-0020 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Yiling Pharmaceutical, Inc. | 69117-0022 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Yiling Pharmaceutical, Inc. | 69117-0023 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-021 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-022 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-023 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Avet Pharmaceuticals Inc. | 23155-965 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Avet Pharmaceuticals Inc. | 23155-963 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Avet Pharmaceuticals Inc. | 23155-964 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Avet Pharmaceuticals Inc. | 23155-966 |