Prescription drug · NDA
Celebrex (Celecoxib) NDC 58151-085
Celecoxib 400 mg/1 · Capsule · Oral · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58151-085-88 | 5815100858858151008588 | 100 BLISTER PACK in 1 CARTON (58151-085-88) / 1 CAPSULE in 1 BLISTER PACK (58151-085-32)Marketed from Oct 11, 2023 | |
| 58151-085-91 | 5815100859158151008591 | 60 CAPSULE in 1 BOTTLE (58151-085-91)Marketed from Sep 12, 2023 |
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)
- Celebrex
- Generic name (nonproprietary)
- celecoxib
- Active ingredients
- Celecoxib — 400 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Viatris Specialty LLCNDC labeler code 58151
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020998
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 58151-085_0c321a7b-89e4-48cc-ab0b-1bd7620d7799SPL ID 0c321a7b-89e4-48cc-ab0b-1bd7620d7799SPL set ID 2d6675e4-5859-4be2-8037-a20ce9f707aaRxCUI 205322, 205323, 213468, 213469, 349514, 352314, 686379, 686381UNII JCX84Q7J1LUPC 0358151085910, 0358151084012, 0358151082919, 0358151083015
- 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
N458151008588followed by a unit qualifier and the quantityPackage 58151-0085-88. 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)
CELEBREX is indicated CELEBREX 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 Studies (14.3…
Excerpt only. Read the full label for complete information.
About NDC 58151-085
- What is NDC 58151-085?
- 58151-085 is the product NDC for Celebrex (celecoxib), Celecoxib 400 mg/1 capsule, listed with the FDA by Viatris Specialty LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Celebrex (Celecoxib).
- What is the active ingredient?
- Celecoxib.
- Who is the labeler?
- Viatris Specialty LLC, NDC labeler code 58151. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Celebrex?
- 3 other product NDCs are listed under this name. See all Celebrex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Celebrex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Celebrexcelecoxib | Celecoxib 100 mg/1 | CapsuleOral | Viatris Specialty LLC | 58151-083 | 58151-0083-0158151-0083-0558151-0083-88 |
| Celebrexcelecoxib | Celecoxib 200 mg/1 | CapsuleOral | Viatris Specialty LLC | 58151-084 | 58151-0084-0158151-0084-0558151-0084-88 |
| Celebrexcelecoxib | Celecoxib 50 mg/1 | CapsuleOral | Viatris Specialty LLC | 58151-082 | 58151-0082-91 |
Other NDCs under NDA 020998
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 |
|---|---|---|---|---|
| Celebrexcelecoxib | Celecoxib 50 mg/1 | CapsuleOral | Viatris Specialty LLC | 58151-082 |
| Celebrexcelecoxib | Celecoxib 100 mg/1 | CapsuleOral | Viatris Specialty LLC | 58151-083 |
| Celebrexcelecoxib | Celecoxib 200 mg/1 | CapsuleOral | Viatris Specialty LLC | 58151-084 |