What is NDC 68180-398?

68180-398 is the product NDC for celecoxib, Celecoxib 400 mg/1 capsule, listed with the FDA by Lupin Pharmaceuticals, Inc..

Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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?

228 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

celecoxib NDC 68180-398 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68180-398Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68180-0398Add the package segment from the table below.

Product information

Brand name (proprietary): celecoxib
Generic name (nonproprietary): celecoxib
Active ingredients: Celecoxib — 400 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.NDC labeler code 68180
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202240
Marketing start: Aug 7, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 68180-398_c7509f8b-4cac-4294-8e22-0e954c75f793SPL ID c7509f8b-4cac-4294-8e22-0e954c75f793SPL set ID 560017b1-daf8-464e-b86f-0a75c78002ecRxCUI 205322, 205323, 349514, 686379UNII JCX84Q7J1LUPC 0368180397014, 0368180398011
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.

Product label

Current FDA label (SPL), effective Dec 8, 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)

About NDC 68180-398

What is NDC 68180-398?: 68180-398 is the product NDC for celecoxib, Celecoxib 400 mg/1 capsule, listed with the FDA by Lupin Pharmaceuticals, Inc..
What drug is associated with this NDC?: celecoxib.
What is the active ingredient?: Celecoxib.
Who is the labeler?: Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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?: 228 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other celecoxib NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
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	60760-0958-1560760-0958-30
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 50 mg/1	CapsuleOral	Avet Pharmaceuticals Inc.	23155-963	23155-0963-06
Celecoxib	Celecoxib 100 mg/1	CapsuleOral	Avet Pharmaceuticals Inc.	23155-964	23155-0964-0123155-0964-05

All 229 celecoxib NDCs

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 200 mg/1	CapsuleOral	A-S Medication Solutions	50090-5638
celecoxib	Celecoxib 50 mg/1	CapsuleOral	Lupin Pharmaceuticals, Inc.	68180-395
celecoxib	Celecoxib 100 mg/1	CapsuleOral	Lupin Pharmaceuticals, Inc.	68180-396
celecoxib	Celecoxib 200 mg/1	CapsuleOral	Lupin Pharmaceuticals, Inc.	68180-399