What is NDC 85534-0067?

85534-0067 is the product NDC for Celecoxib, Celecoxib 100 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 85534-0067 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)85534-0067Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85534-0067Add 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
85534-0067-0	8553400670085534006700	30 CAPSULE in 1 BOTTLE (85534-0067-0)Marketed from Sep 7, 2026
85534-0067-1	8553400670185534006701	60 CAPSULE in 1 BOTTLE (85534-0067-1)Marketed from Sep 7, 2026
85534-0067-2	8553400670285534006702	90 CAPSULE in 1 BOTTLE (85534-0067-2)Marketed from Sep 7, 2026
85534-0067-3	8553400670385534006703	120 CAPSULE in 1 BOTTLE (85534-0067-3)Marketed from Sep 7, 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 — 100 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 205129
Marketing start: Dec 3, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 85534-0067_562a892c-2da6-2207-e063-6294a90a82a4SPL ID 562a892c-2da6-2207-e063-6294a90a82a4SPL set ID 77f3b90b-a25d-4c47-975a-2a988d696a3fRxCUI 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

N485534006700 followed by a unit qualifier and the quantity

Package 85534-0067-00. 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)

1. INDICATIONS AND USAGE Celecoxib capsules are indicated Celecoxib capsules are 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 old…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85534-0067

What is NDC 85534-0067?: 85534-0067 is the product NDC for Celecoxib, Celecoxib 100 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 205129

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

FDA NDC Directory listings under ANDA 205129
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 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
Celecoxib	Celecoxib 200 mg/1	CapsuleOral	PHOENIX RX LLC	85509-1158

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