Prescription drug · ANDA
Celecoxib NDC 72189-123
Celecoxib 100 mg/1 · Capsule · Oral · Direct Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-123-30 | 7218901233072189012330 | 30 CAPSULE in 1 BOTTLE (72189-123-30)Marketed from Aug 10, 2020 | |
| 72189-123-60 | 7218901236072189012360 | 60 CAPSULE in 1 BOTTLE (72189-123-60)Marketed from Aug 10, 2020 | |
| 72189-123-71 | 7218901237172189012371 | 100 CAPSULE in 1 BOTTLE (72189-123-71)Marketed from Aug 10, 2020 | |
| 72189-123-72 | 7218901237272189012372 | 120 CAPSULE in 1 BOTTLE (72189-123-72)Marketed from Aug 10, 2020 | |
| 72189-123-90 | 7218901239072189012390 | 90 CAPSULE in 1 BOTTLE (72189-123-90)Marketed from Aug 10, 2020 |
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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Direct RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204590
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 72189-123_4c5d46ae-1be9-64a4-e063-6294a90ac02bSPL ID 4c5d46ae-1be9-64a4-e063-6294a90ac02bSPL set ID ac87b4f9-3f66-8cf7-e053-2995a90ade0fRxCUI 205322UNII 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
N472189012330followed by a unit qualifier and the quantityPackage 72189-0123-30. 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 capsules are indicated 1.1 Osteoarthritis For the management of the signs and symptoms of OA [see Clinical Studies (14.1)] 1.2 Rheumatoid Arthritis For the management of the signs and symptoms of RA [see Clinical Studies (14.2)] 1.3 Juvenile Rheumatoid Arthritis For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)] 1.4 Ankylosing Spondylitis For the management of the signs and symptoms of AS [see Clinical Studies (14.4)] 1.5 Acute Pain For the management of acute pain in adults [see Clinical Studies (14.5)] 1.6 Primary Dysmenorrhea For the management of primary dysmenorrhea [see Clinical Studies (14.5)]
Excerpt only. Read the full label for complete information.
About NDC 72189-123
- What is NDC 72189-123?
- 72189-123 is the product NDC for Celecoxib, Celecoxib 100 mg/1 capsule, listed with the FDA by Direct Rx. It has 5 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?
- Direct Rx, NDC labeler code 72189. 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 204590
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 | Asclemed USA, Inc. | 76420-243 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-967 |
| celecoxib | Celecoxib 50 mg/1 | CapsuleOral | HAWAII REPACK, INC. | 85534-0059 |
| celecoxib | Celecoxib 400 mg/1 | CapsuleOral | HAWAII REPACK, INC. | 85534-0060 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | HAWAII REPACK, INC. | 85534-0065 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4392 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0167 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0868 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-7264 |
| celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-7286 |
| celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Sportpharm LLC | 85766-030 |
| celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0936 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Proficient Rx LP | 71205-027 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-009 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2489 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0037 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-253 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0323 |
| celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-439 |
| celecoxib | Celecoxib 200 mg/1 | CapsuleOral | RedPharm Drug, Inc. | 67296-1399 |
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