Celecoxib NDC 83008-013

NDC codes

FDA NDC Directory

Product NDC (as listed)83008-013Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83008-0013Add 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	Copy
83008-013-30	83008001330	30 CAPSULE in 1 BOTTLE (83008-013-30)Marketed from Apr 25, 2023
83008-013-60	83008001360	60 CAPSULE in 1 BOTTLE (83008-013-60)Marketed from Apr 25, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: Quality Care Products, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205129
Marketing start: Apr 25, 2023
Marketing end: Jun 30, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 83008-013_92c08da3-b8ec-4335-8c40-d1f1159a629dSPL ID 92c08da3-b8ec-4335-8c40-d1f1159a629dSPL set ID fcf49d7f-8319-4051-b7ac-fe063268b39bRxCUI 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

N483008001330 followed by a unit qualifier and the quantity

Package 83008-0013-30. 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 19, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Celecoxib is indicated 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 ) 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 100 mg/1	CapsuleOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-649
Celecoxib	Celecoxib 200 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-3733
Celecoxib	Celecoxib 200 mg/1	CapsuleOral	Sportpharm LLC	85766-009
Celecoxib	Celecoxib 200 mg/1	CapsuleOral	Medsource Pharmaceuticals	45865-234
Celecoxib	Celecoxib 100 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc.	50228-157
Celecoxib	Celecoxib 50 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc.	50228-156
Celecoxib	Celecoxib 200 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc.	50228-158
Celecoxib	Celecoxib 400 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc.	50228-159
Celecoxib	Celecoxib 200 mg/1	CapsuleOral	St Mary's Medical Park Pharmacy	60760-742
Celecoxib	Celecoxib 200 mg/1	CapsuleOral	Proficient Rx LP	71205-664
Celecoxib	Celecoxib 200 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-8197
Celecoxib	Celecoxib 200 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-584
Celecoxib	Celecoxib 100 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2254
Celecoxib	Celecoxib 200 mg/1	CapsuleOral	PHOENIX RX LLC	85509-1158
Celecoxib	Celecoxib 100 mg/1	CapsuleOral	Preferred Pharmaceuticals, Inc.	68788-8206
Celecoxib	Celecoxib 200 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2220
Celecoxib	Celecoxib 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2222
Celecoxib	Celecoxib 400 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4619
Celecoxib	Celecoxib 100 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-843
Celecoxib	Celecoxib 50 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-842

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