What is NDC 80425-0281?

80425-0281 is the product NDC for Celecoxib, Celecoxib 200 mg/1 capsule, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 80425-0281 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0281Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0281Add 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
80425-0281-1	8042502810180425028101	30 CAPSULE in 1 BOTTLE (80425-0281-1)Marketed from Mar 3, 2023
80425-0281-2	8042502810280425028102	60 CAPSULE in 1 BOTTLE (80425-0281-2)Marketed from Mar 3, 2023
80425-0281-3	8042502810380425028103	90 CAPSULE in 1 BOTTLE (80425-0281-3)Marketed from Mar 3, 2023
80425-0281-4	8042502810480425028104	180 CAPSULE in 1 BOTTLE (80425-0281-4)Marketed from Mar 3, 2023

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: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210628
Marketing start: Mar 3, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 80425-0281_2a9ba8f4-6cea-e827-e063-6394a90a0300SPL ID 2a9ba8f4-6cea-e827-e063-6394a90a0300SPL set ID f60394f5-fd69-929b-e053-2995a90a5793RxCUI 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

N480425028101 followed by a unit qualifier and the quantity

Package 80425-0281-01. 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 Dec 31, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

1. Indications and Usage Celecoxib capsule are indicated 1.1 Osteoarthritis For the management of the signs and symptoms of OA [ see CLINICAL STUDIES (14.1)]. 1.2 Rheumatoid Arthritis For the management of the signs and symptoms of RA [ see CLINICAL STUDIES (14.2)]. 1.3 Juvenile Rheumatoid Arthritis For the management of the signs and symptoms of JRA in patients 2 years and older [ see CLINICAL STUDIES (14.3)]. 1.4 Ankylosing Spondylitis For the management of the signs and symptoms of AS [ see CLINICAL STUDIES (14.4)]. 1.5 Acute Pain For the management of acute pain in adults [ see CLINICAL STUDIES (14.5)]. 1.6 Primary Dysmenorrhea For the management of primary dysmenorrhea [ see CLINICAL ST…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0281

What is NDC 80425-0281?: 80425-0281 is the product NDC for Celecoxib, Celecoxib 200 mg/1 capsule, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. 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?: Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 210628

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

FDA NDC Directory listings under ANDA 210628
Product	Strength	Form · route	Labeler	Product NDC
Celecoxib	Celecoxib 50 mg/1	CapsuleOral	Umedica Laboratories USA Inc.	60290-016
Celecoxib	Celecoxib 100 mg/1	CapsuleOral	Umedica Laboratories USA Inc.	60290-017
Celecoxib	Celecoxib 200 mg/1	CapsuleOral	Umedica Laboratories USA Inc.	60290-018
Celecoxib	Celecoxib 400 mg/1	CapsuleOral	Umedica Laboratories USA Inc.	60290-019
Celecoxib	Celecoxib 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-3424
Celecoxib	Celecoxib 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2019
Celecoxib	Celecoxib 200 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2357
Celecoxib	Celecoxib 50 mg/1	CapsuleOral	NIVAGEN PHARMACEUTICALS, INC.	75834-236
Celecoxib	Celecoxib 100 mg/1	CapsuleOral	NIVAGEN PHARMACEUTICALS, INC.	75834-237
Celecoxib	Celecoxib 200 mg/1	CapsuleOral	NIVAGEN PHARMACEUTICALS, INC.	75834-238
Celecoxib	Celecoxib 400 mg/1	CapsuleOral	NIVAGEN PHARMACEUTICALS, INC.	75834-239
Celecoxib	Celecoxib 100 mg/1	CapsuleOral	PHOENIX RX LLC	85509-1237