Prescription drug · ANDA
Celecoxib NDC 72189-360
Celecoxib 200 mg/1 · Capsule · Oral · DirectRx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-360-10 | 7218903601072189036010 | 10 CAPSULE in 1 BOTTLE (72189-360-10)Marketed from Jun 8, 2022 | |
| 72189-360-30 | 7218903603072189036030 | 30 CAPSULE in 1 BOTTLE (72189-360-30)Marketed from Jun 8, 2022 | |
| 72189-360-42 | 7218903604272189036042 | 42 CAPSULE in 1 BOTTLE (72189-360-42)Marketed from Jun 8, 2022 | |
| 72189-360-60 | 7218903606072189036060 | 60 CAPSULE in 1 BOTTLE (72189-360-60)Marketed from Jun 8, 2022 | |
| 72189-360-72 | 7218903607272189036072 | 120 CAPSULE in 1 BOTTLE (72189-360-72)Marketed from Jun 8, 2022 | |
| 72189-360-90 | 7218903609072189036090 | 90 CAPSULE in 1 BOTTLE (72189-360-90)Marketed from Jun 8, 2022 |
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
- DirectRxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205129
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 72189-360_5a0b313a-2ab3-0d47-e063-6394a90ad440SPL ID 5a0b313a-2ab3-0d47-e063-6394a90ad440SPL set ID e0f3aacf-df5d-dad7-e053-2995a90ac5ebRxCUI 205323UNII 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
N472189036010followed by a unit qualifier and the quantityPackage 72189-0360-10. 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 .
Indications (excerpt from the label)
Celecoxib is 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 (14.3)] 1.4 Ankylosing Spondylitis (AS) 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 72189-360
- What is NDC 72189-360?
- 72189-360 is the product NDC for Celecoxib, Celecoxib 200 mg/1 capsule, listed with the FDA by DirectRx. It has 6 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?
- DirectRx, 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 205129
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 200 mg/1 | CapsuleOral | Radha Pharmaceuticals, Inc. | 77771-158 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | Radha Pharmaceuticals, Inc. | 77771-156 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Radha Pharmaceuticals, Inc. | 77771-157 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | Radha Pharmaceuticals, Inc. | 77771-159 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | HAWAII REPACK, INC. | 85534-0066 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | HAWAII REPACK, INC. | 85534-0067 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | HAWAII REPACK, INC. | 85534-0068 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3733 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-649 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Quality Care Products, LLC | 83008-013 |
| Celecoxib | Celecoxib 400 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc. | 50228-159 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Sportpharm LLC | 85766-009 |
| Celecoxib | Celecoxib 50 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc. | 50228-156 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc. | 50228-157 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | St Mary's Medical Park Pharmacy | 60760-742 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc. | 50228-158 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-8197 |
| Celecoxib | Celecoxib 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-8206 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2175 |
| Celecoxib | Celecoxib 200 mg/1 | CapsuleOral | PHOENIX RX LLC | 85509-1158 |
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