NDC codes

FDA NDC Directory
Product NDC (as listed)72162-2357Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72162-2357Add 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
72162-2357-172162235701100 CAPSULE in 1 BOTTLE (72162-2357-1)Marketed from Sep 3, 2020
72162-2357-572162235705500 CAPSULE in 1 BOTTLE (72162-2357-5)Marketed from Sep 3, 2020

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210628
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 72162-2357_874f6977-fcbf-4160-9810-97c2203cd00fSPL ID 874f6977-fcbf-4160-9810-97c2203cd00fSPL set ID 47be1d99-eebb-42f9-80d9-291a024b1364RxCUI 205323UNII JCX84Q7J1L

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

N472162235701 followed by a unit qualifier and the quantity

Package 72162-2357-01. 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)

1. INDICATIONS AND USAGE Celecoxib capsule 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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
ProductStrengthForm · routeLabelerProduct NDC
CelecoxibCelecoxib 50 mg/1CapsuleOralNIVAGEN PHARMACEUTICALS, INC.75834-236
CelecoxibCelecoxib 100 mg/1CapsuleOralNIVAGEN PHARMACEUTICALS, INC.75834-237
CelecoxibCelecoxib 200 mg/1CapsuleOralNIVAGEN PHARMACEUTICALS, INC.75834-238
CelecoxibCelecoxib 400 mg/1CapsuleOralNIVAGEN PHARMACEUTICALS, INC.75834-239
CelecoxibCelecoxib 100 mg/1CapsuleOralPHOENIX RX LLC85509-1237
CelecoxibCelecoxib 200 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0281
CelecoxibCelecoxib 100 mg/1CapsuleOralREMEDYREPACK INC.70518-3424
CelecoxibCelecoxib 100 mg/1CapsuleOralBryant Ranch Prepack71335-2019
CelecoxibCelecoxib 100 mg/1CapsuleOralUmedica Laboratories USA Inc.60290-017
CelecoxibCelecoxib 50 mg/1CapsuleOralUmedica Laboratories USA Inc.60290-016
CelecoxibCelecoxib 200 mg/1CapsuleOralUmedica Laboratories USA Inc.60290-018
CelecoxibCelecoxib 400 mg/1CapsuleOralUmedica Laboratories USA Inc.60290-019

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