NDC codes

FDA NDC Directory
Product NDC (as listed)68462-179Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0179Add 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
68462-179-0168462017901100 TABLET in 1 BOTTLE (68462-179-01)Marketed from Aug 1, 2007
68462-179-0568462017905500 TABLET in 1 BOTTLE (68462-179-05)Marketed from Aug 1, 2007

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)
Naproxen Sodium
Generic name (nonproprietary)
naproxen sodium
Active ingredients
Naproxen sodium — 550 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078314
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 68462-179_16372549-a419-4920-a200-5128017570edSPL ID 16372549-a419-4920-a200-5128017570edSPL set ID 6c5bb008-e66f-4ef0-bf84-aca7eb5983e9RxCUI 198012, 198013, 198014, 849398, 849431UNII 57Y76R9ATQ, 9TN87S3A3CUPC 0368462189016, 0368462178010, 0368462179017, 0368462188019, 0368462190012

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

N468462017901 followed by a unit qualifier and the quantity

Package 68462-0179-01. 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)

Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets and naproxen sodium tablets are also indicated for: the relief of signs and symptoms of: • tendonitis • bursitis • acute gout the management of: • pain • primary dysmenorrhea Naproxen tablets and naproxen sodium tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • polyarticular juvenile idiopathic arthritis Naproxen tablets and naproxen sodium t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078314

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

FDA NDC Directory listings under ANDA 078314
ProductStrengthForm · routeLabelerProduct NDC
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralBryant Ranch Prepack71335-3075
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0532
Naproxen SodiumNaproxen sodium 275 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-178

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in