Celecoxib NDC 29300-158

NDC codes

FDA NDC Directory

Product NDC (as listed)29300-158Labeler and product segments. Claims need a package NDC.

Product NDC at billing width29300-0158Add 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
29300-158-01	29300015801	100 CAPSULE in 1 BOTTLE (29300-158-01)Marketed from Aug 1, 2021
29300-158-05	29300015805	500 CAPSULE in 1 BOTTLE (29300-158-05)Marketed from Aug 1, 2021

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 — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Unichem Pharmaceuticals (USA), Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213301
Marketing start: Jan 12, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 29300-158_fbb9cff1-8a87-4280-a3f1-4d0560d65b0dSPL ID fbb9cff1-8a87-4280-a3f1-4d0560d65b0dSPL set ID 0e8484a8-04a6-4be3-8c5c-1883b0490d53RxCUI 205322, 205323, 349514, 686379UNII JCX84Q7J1LUPC 0329300374162, 0329300373011
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

N429300015801 followed by a unit qualifier and the quantity

Package 29300-0158-01. 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 18, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

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 older [ see Clinical S…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213301

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

FDA NDC Directory listings under ANDA 213301
Product	Strength	Form · route	Labeler	Product NDC
Celecoxib	Celecoxib 50 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-157
Celecoxib	Celecoxib 200 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-373
Celecoxib	Celecoxib 400 mg/1	CapsuleOral	Unichem Pharmaceuticals (USA), Inc.	29300-374