NDC codes

FDA NDC Directory
Product NDC (as listed)13668-442Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13668-0442Add 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 NDC11-digit (billing)PackageCopy
13668-442-0113668044201100 CAPSULE in 1 BOTTLE (13668-442-01)Marketed from Dec 23, 2015
13668-442-0513668044205500 CAPSULE in 1 BOTTLE (13668-442-05)Marketed from Dec 23, 2015
13668-442-10136680442101000 CAPSULE in 1 BOTTLE (13668-442-10)Marketed from Dec 23, 2015
13668-442-301366804423030 CAPSULE in 1 BOTTLE (13668-442-30)Marketed from Dec 23, 2015
13668-442-601366804426060 CAPSULE in 1 BOTTLE (13668-442-60)Marketed from Dec 23, 2015
13668-442-901366804429090 CAPSULE in 1 BOTTLE (13668-442-90)Marketed from Dec 23, 2015

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207677
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 13668-442_bff3a32b-43e3-46cd-b5c3-b691617fe4faSPL ID bff3a32b-43e3-46cd-b5c3-b691617fe4faSPL set ID 862698b6-2cc9-4374-992d-024beae6eba3RxCUI 205322, 205323, 349514, 686379UNII JCX84Q7J1LUPC 0313668441307, 0313668307306, 0313668310306

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

N413668044201 followed by a unit qualifier and the quantity

Package 13668-0442-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

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 ) Celecoxib is indicated 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 Studies ( 14.3 )] . 1…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207677

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

FDA NDC Directory listings under ANDA 207677
ProductStrengthForm · routeLabelerProduct NDC
celecoxibCelecoxib 400 mg/1CapsuleOralTorrent Pharmaceuticals Limited13668-310
celecoxibCelecoxib 100 mg/1CapsuleOralTorrent Pharmaceuticals Limited13668-441
celecoxibCelecoxib 50 mg/1CapsuleOralTorrent Pharmaceuticals Limited13668-307

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celecoxib NDC 13668-442 | Med-Code