NDC codes

FDA NDC Directory
Product NDC (as listed)63187-535Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0535Add 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
63187-535-156318705351515 TABLET in 1 BOTTLE (63187-535-15)Marketed from Dec 1, 2018
63187-535-206318705352020 TABLET in 1 BOTTLE (63187-535-20)Marketed from Dec 1, 2018
63187-535-306318705353030 TABLET in 1 BOTTLE (63187-535-30)Marketed from Dec 1, 2018
63187-535-456318705354545 TABLET in 1 BOTTLE (63187-535-45)Marketed from Dec 1, 2018
63187-535-606318705356060 TABLET in 1 BOTTLE (63187-535-60)Marketed from Dec 1, 2018
63187-535-906318705359090 TABLET in 1 BOTTLE (63187-535-90)Marketed from Dec 1, 2018

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
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078250
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 63187-535_bd0691c5-aaa9-472e-9b05-926d93defd0cSPL ID bd0691c5-aaa9-472e-9b05-926d93defd0cSPL set ID 3e4e5371-d796-47c7-95c1-d99e82a0b282RxCUI 198012UNII 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

N463187053515 followed by a unit qualifier and the quantity

Package 63187-0535-15. 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)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen or naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Naproxen as naproxen tablets or naproxen sodium tablets are indicated: • For the relief of the signs and symptoms of rheumatoid arthritis • For the relief of the signs and symptoms of osteoarthritis • For the relief of the signs and symptoms of ankylosing spondylitis • For the relief of the signs and symptoms of juvenile arthritis Naproxen as naproxen suspension is recommended for j…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-535

What is NDC 63187-535?
63187-535 is the product NDC for Naproxen, Naproxen 375 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 6 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?
Proficient Rx LP, NDC labeler code 63187. 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 078250

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

FDA NDC Directory listings under ANDA 078250
ProductStrengthForm · routeLabelerProduct NDC
NaproxenNaproxen 375 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8844
NaproxenNaproxen 375 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-189
NaproxenNaproxen 250 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-188
NaproxenNaproxen 500 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-190
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-7198
NaproxenNaproxen 500 mg/1TabletOralBryant Ranch Prepack71335-2485
NaproxenNaproxen 250 mg/1TabletOralProficient Rx LP63187-461
NaproxenNaproxen 500 mg/1TabletOralREMEDYREPACK INC.70518-1516
NaproxenNaproxen 500 mg/1TabletOralProficient Rx LP63187-028
NaproxenNaproxen 375 mg/1TabletOralBryant Ranch Prepack71335-0095
NaproxenNaproxen 500 mg/1TabletOralBoswell Pharmacy Services LLC d/b/a BPS Wholesale83209-190
NaproxenNaproxen 250 mg/1TabletOralBryant Ranch Prepack71335-0217
NaproxenNaproxen 375 mg/1TabletOralA-S Medication Solutions50090-1584
NaproxenNaproxen 375 mg/1TabletOralA-S Medication Solutions50090-1583
NaproxenNaproxen 250 mg/1TabletOralA-S Medication Solutions50090-2788
NaproxenNaproxen 500 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-153
NaproxenNaproxen 375 mg/1TabletOralA-S Medication Solutions50090-1585
NaproxenNaproxen 500 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-807
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-0481
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-0482

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