NDC codes

FDA NDC Directory
Product NDC (as listed)59651-986Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0986Add 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
59651-986-0159651098601100 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-986-01)Marketed from May 8, 2025
59651-986-0559651098605500 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-986-05)Marketed from May 8, 2025

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
Generic name (nonproprietary)
naproxen
Active ingredients
Naproxen — 375 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075390
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 59651-986_edd3093b-122c-41c4-9426-f1da6f21a241SPL ID edd3093b-122c-41c4-9426-f1da6f21a241SPL set ID 67815abd-5e97-4ccb-ac9b-28c2ef6123e7RxCUI 311915, 603103UNII 57Y76R9ATQ

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

N459651098601 followed by a unit qualifier and the quantity

Package 59651-0986-01. 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 delayed-release tablets are indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis Naproxen delayed-release 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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-986

What is NDC 59651-986?
59651-986 is the product NDC for Naproxen, Naproxen 375 mg/1 tablet, delayed release, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Naproxen.
What is the active ingredient?
Naproxen.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Naproxen?
185 other product NDCs are listed under this name. See all Naproxen NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Naproxen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
NaproxenNaproxen 500 mg/1TabletOralREMEDYREPACK INC.70518-475070518-4750-00
NaproxenNaproxen 500 mg/1TabletOralCoupler LLC67046-078467046-0784-03
NaproxenNaproxen 250 mg/1TabletOralCoupler LLC67046-049967046-0499-03
NaproxenNaproxen 375 mg/1TabletOralCoupler LLC67046-050067046-0500-03
NaproxenNaproxen 500 mg/1TabletOralCoupler LLC67046-050167046-0501-03
NaproxenNaproxen 375 mg/1Tablet, Delayed releaseOralSunrise Pharmaceutical, Inc.11534-21111534-0211-01
NaproxenNaproxen 500 mg/1Tablet, Delayed releaseOralSunrise Pharmaceutical, Inc.11534-21211534-0212-01
NaproxenNaproxen 250 mg/1TabletOralREMEDYREPACK INC.70518-451470518-4514-00
NaproxenNaproxen 500 mg/1TabletOralMedcore LLC82461-71182461-0711-60
NaproxenNaproxen 125 mg/5mLSuspensionOralAurobindo Pharma Limited59651-52859651-0528-47

All 186 Naproxen NDCs

Other NDCs under ANDA 075390

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

FDA NDC Directory listings under ANDA 075390
ProductStrengthForm · routeLabelerProduct NDC
NaproxenNaproxen 500 mg/1Tablet, Delayed releaseOralAurobindo Pharma Limited59651-987

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