What is NDC 85534-0065?

85534-0065 is the product NDC for celecoxib, Celecoxib 200 mg/1 capsule, listed with the FDA by HAWAII REPACK, INC.. It has 4 package NDCs, shown above in 10- and 11-digit form.

HAWAII REPACK, INC., NDC labeler code 85534. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

celecoxib NDC 85534-0065 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)85534-0065Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85534-0065Add 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
85534-0065-0	8553400650085534006500	30 CAPSULE in 1 BOTTLE (85534-0065-0)Marketed from Jul 9, 2026
85534-0065-1	8553400650185534006501	60 CAPSULE in 1 BOTTLE (85534-0065-1)Marketed from Jul 9, 2026
85534-0065-2	8553400650285534006502	90 CAPSULE in 1 BOTTLE (85534-0065-2)Marketed from Jul 9, 2026
85534-0065-3	8553400650385534006503	120 CAPSULE in 1 BOTTLE (85534-0065-3)Marketed from Jul 9, 2026

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: HAWAII REPACK, INC.NDC labeler code 85534
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204590
Marketing start: Mar 16, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 85534-0065_562805ed-2a9f-f1c8-e063-6294a90a50ffSPL ID 562805ed-2a9f-f1c8-e063-6294a90a50ffSPL set ID 45816eae-ad83-4d2f-a035-c3f9f24708f9RxCUI 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

N485534006500 followed by a unit qualifier and the quantity

Package 85534-0065-00. 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 Jul 9, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Celecoxib capsules are indicated Celecoxib capsules are 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85534-0065

What is NDC 85534-0065?: 85534-0065 is the product NDC for celecoxib, Celecoxib 200 mg/1 capsule, listed with the FDA by HAWAII REPACK, INC.. It has 4 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?: HAWAII REPACK, INC., NDC labeler code 85534. 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.

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 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

All 231 celecoxib NDCs

Other NDCs under ANDA 204590

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

FDA NDC Directory listings under ANDA 204590
Product	Strength	Form · route	Labeler	Product NDC
celecoxib	Celecoxib 100 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-243
celecoxib	Celecoxib 200 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	43063-967
celecoxib	Celecoxib 50 mg/1	CapsuleOral	HAWAII REPACK, INC.	85534-0059
celecoxib	Celecoxib 400 mg/1	CapsuleOral	HAWAII REPACK, INC.	85534-0060
celecoxib	Celecoxib 200 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-4392
Celecoxib	Celecoxib 100 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0167
celecoxib	Celecoxib 200 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-0868
celecoxib	Celecoxib 200 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-7264
celecoxib	Celecoxib 100 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-7286
celecoxib	Celecoxib 400 mg/1	CapsuleOral	Sportpharm LLC	85766-030
celecoxib	Celecoxib 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-0936
celecoxib	Celecoxib 200 mg/1	CapsuleOral	Proficient Rx LP	71205-027
celecoxib	Celecoxib 200 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-009
Celecoxib	Celecoxib 100 mg/1	CapsuleOral	Direct Rx	72189-123
celecoxib	Celecoxib 200 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2489
Celecoxib	Celecoxib 200 mg/1	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0037
celecoxib	Celecoxib 200 mg/1	CapsuleOral	Northwind Health Company, LLC	51655-253
Celecoxib	Celecoxib 100 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0323
celecoxib	Celecoxib 100 mg/1	CapsuleOral	Proficient Rx LP	71205-439
celecoxib	Celecoxib 200 mg/1	CapsuleOral	RedPharm Drug, Inc.	67296-1399

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