NDC codes

FDA NDC Directory
Product NDC (as listed)65862-516Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0516Add 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
65862-516-0165862051601100 TABLET, FILM COATED in 1 BOTTLE (65862-516-01)Marketed from Oct 31, 2011
65862-516-0565862051605500 TABLET, FILM COATED in 1 BOTTLE (65862-516-05)Marketed from Oct 31, 2011
65862-516-26658620516262500 TABLET, FILM COATED in 1 BOTTLE (65862-516-26)Marketed from Oct 31, 2011
65862-516-306586205163030 TABLET, FILM COATED in 1 BOTTLE (65862-516-30)Marketed from Oct 31, 2011

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, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200629
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 65862-516_a4659cf5-a74b-42b3-968b-a8e4f14f94aaSPL ID a4659cf5-a74b-42b3-968b-a8e4f14f94aaSPL set ID 37b264f9-b46d-4635-8fab-246b1e08b653RxCUI 849398, 849431UNII 9TN87S3A3C

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

N465862051601 followed by a unit qualifier and the quantity

Package 65862-0516-01. 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 sodium tablets are indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis tendonitis bursitis acute gout the management of: pain primary dysmenorrhea Naproxen sodium tablets are non-steroidal anti-inflammatory drugs indicated for: ( 1 ) the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis tendonitis bursitis acute gout the management of: pain primary dysmenorrhea

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200629

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

FDA NDC Directory listings under ANDA 200629
ProductStrengthForm · routeLabelerProduct NDC
Naproxen SodiumNaproxen sodium 550 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0822
Naproxen SodiumNaproxen sodium 275 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1925
Naproxen SodiumNaproxen sodium 275 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-515
Naproxen SodiumNaproxen sodium 550 mg/1Tablet, Film coatedOralProficient Rx LP71205-479

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Naproxen Sodium NDC 65862-516 | Med-Code