celecoxib NDC 50090-5638

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-5638Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-5638Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
50090-5638-0	50090563800	30 CAPSULE in 1 BOTTLE (50090-5638-0)Marketed from Sep 3, 2021
50090-5638-1	50090563801	60 CAPSULE in 1 BOTTLE (50090-5638-1)Marketed from Sep 3, 2021
50090-5638-2	50090563802	90 CAPSULE in 1 BOTTLE (50090-5638-2)Marketed from Sep 9, 2021

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 — 200 mg/1
Dosage form: Capsule
Route: Oral
Labeler: A-S Medication Solutions
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202240
Marketing start: Dec 9, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 50090-5638_0d540a4e-27a4-4acc-b51c-5e6f9873ddedSPL ID 0d540a4e-27a4-4acc-b51c-5e6f9873ddedSPL set ID 85bfe02b-bfcb-44ee-81a0-11765c3054a9RxCUI 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

N450090563800 followed by a unit qualifier and the quantity

Package 50090-5638-00. 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 Feb 6, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

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 ) Celecoxib capsules are 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)]…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202240

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 202240
Product	Strength	Form · route	Labeler	Product NDC
celecoxib	Celecoxib 50 mg/1	CapsuleOral	Lupin Pharmaceuticals, Inc.	68180-395
celecoxib	Celecoxib 100 mg/1	CapsuleOral	Lupin Pharmaceuticals, Inc.	68180-396
celecoxib	Celecoxib 400 mg/1	CapsuleOral	Lupin Pharmaceuticals, Inc.	68180-398
celecoxib	Celecoxib 200 mg/1	CapsuleOral	Lupin Pharmaceuticals, Inc.	68180-399