Prescription drug · ANDA
Celecoxib NDC 76420-843
Celecoxib 100 mg/1 · Capsule · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-843-00 | 7642008430076420084300 | 1000 CAPSULE in 1 BOTTLE (76420-843-00)Marketed from Aug 17, 2024 | |
| 76420-843-01 | 7642008430176420084301 | 1 CAPSULE in 1 BOTTLE (76420-843-01)Marketed from Aug 17, 2024 | |
| 76420-843-05 | 7642008430576420084305 | 500 CAPSULE in 1 BOTTLE (76420-843-05)Marketed from Aug 17, 2024 | |
| 76420-843-07 | 7642008430776420084307 | 7 CAPSULE in 1 BOTTLE (76420-843-07)Marketed from Aug 17, 2024 | |
| 76420-843-10 | 7642008431076420084310 | 100 CAPSULE in 1 BOTTLE (76420-843-10)Marketed from Aug 17, 2024 | |
| 76420-843-14 | 7642008431476420084314 | 14 CAPSULE in 1 BOTTLE (76420-843-14)Marketed from Aug 17, 2024 | |
| 76420-843-20 | 7642008432076420084320 | 20 CAPSULE in 1 BOTTLE (76420-843-20)Marketed from Aug 17, 2024 | |
| 76420-843-30 | 7642008433076420084330 | 30 CAPSULE in 1 BOTTLE (76420-843-30)Marketed from Aug 17, 2024 | |
| 76420-843-60 | 7642008436076420084360 | 60 CAPSULE in 1 BOTTLE (76420-843-60)Marketed from Aug 17, 2024 | |
| 76420-843-90 | 7642008439076420084390 | 90 CAPSULE in 1 BOTTLE (76420-843-90)Marketed from Aug 17, 2024 |
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
- Asclemed USA, Inc.NDC labeler code 76420
- 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 76420-843_327a5fba-3c08-7bba-e063-6294a90a75e5SPL ID 327a5fba-3c08-7bba-e063-6294a90a75e5SPL set ID 5d0dcac1-237c-47aa-bcfb-50fa20b5b838RxCUI 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
N476420084300followed by a unit qualifier and the quantityPackage 76420-0843-00. 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 is indicated Celecoxib 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 Clinical …
Excerpt only. Read the full label for complete information.
About NDC 76420-843
- What is NDC 76420-843?
- 76420-843 is the product NDC for Celecoxib, Celecoxib 100 mg/1 capsule, listed with the FDA by Asclemed USA, Inc.. It has 10 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?
- Asclemed USA, Inc., NDC labeler code 76420. 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 | DirectRx | 72189-360 |
| 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 |
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