Prescription drug · ANDA

Naproxen NDC 71335-2485

Naproxen 500 mg/1 · Tablet · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2485Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2485Add 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
71335-2485-07133524850028 TABLET in 1 BOTTLE (71335-2485-0)Marketed from Sep 3, 2024
71335-2485-17133524850130 TABLET in 1 BOTTLE (71335-2485-1)Marketed from Sep 3, 2024
71335-2485-27133524850260 TABLET in 1 BOTTLE (71335-2485-2)Marketed from Sep 3, 2024
71335-2485-37133524850310 TABLET in 1 BOTTLE (71335-2485-3)Marketed from Sep 3, 2024
71335-2485-47133524850490 TABLET in 1 BOTTLE (71335-2485-4)Marketed from Sep 3, 2024
71335-2485-57133524850520 TABLET in 1 BOTTLE (71335-2485-5)Marketed from Sep 3, 2024
71335-2485-671335248506120 TABLET in 1 BOTTLE (71335-2485-6)Marketed from Sep 3, 2024
71335-2485-77133524850714 TABLET in 1 BOTTLE (71335-2485-7)Marketed from Sep 3, 2024
71335-2485-87133524850842 TABLET in 1 BOTTLE (71335-2485-8)Marketed from Sep 3, 2024
71335-2485-97133524850940 TABLET in 1 BOTTLE (71335-2485-9)Marketed from Sep 3, 2024

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)
Naproxen
Generic name (nonproprietary)
naproxen
Active ingredients
Naproxen — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
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 71335-2485_7f075beb-f2b7-40e2-a4f4-a220bf1a2ac7SPL ID 7f075beb-f2b7-40e2-a4f4-a220bf1a2ac7SPL set ID 1fe9a6fc-940e-4a18-b3e9-b204fd67f263RxCUI 198014UNII 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

N471335248500 followed by a unit qualifier and the quantity

Package 71335-2485-00. 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)

About NDC 71335-2485

What is NDC 71335-2485?
71335-2485 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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?
184 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 185 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 500 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-807
NaproxenNaproxen 500 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-153
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 375 mg/1TabletOralA-S Medication Solutions50090-1585
NaproxenNaproxen 500 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-489
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-0481
NaproxenNaproxen 500 mg/1TabletOralAmerican Health Packaging60687-491
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-0482
NaproxenNaproxen 500 mg/1TabletOralA-S Medication Solutions50090-0483
NaproxenNaproxen 500 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8797
NaproxenNaproxen 250 mg/1TabletOralCoupler LLC67046-0499
NaproxenNaproxen 375 mg/1TabletOralCoupler LLC67046-0500
NaproxenNaproxen 500 mg/1TabletOralCoupler LLC67046-0501
NaproxenNaproxen 375 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8844
NaproxenNaproxen 500 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-190
NaproxenNaproxen 250 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-188
NaproxenNaproxen 375 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-189
NaproxenNaproxen 500 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0050

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Naproxen NDC 71335-2485 | National Drug Code | Med-Code