Prescription drug · ANDA

Naproxen NDC 80425-0048

Naproxen 375 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0048Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0048Add 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
80425-0048-18042500480160 TABLET in 1 BOTTLE (80425-0048-1)Marketed from Jul 6, 2016

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 — 375 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091416
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 80425-0048_2a98d9c1-b76d-40b1-e063-6294a90a20e4SPL ID 2a98d9c1-b76d-40b1-e063-6294a90a20e4SPL set ID af9a96cf-1cda-8ace-e053-2a95a90a18ccRxCUI 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

N480425004801 followed by a unit qualifier and the quantity

Package 80425-0048-01. 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)

1. Indications and Usage Naproxen 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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0048

What is NDC 80425-0048?
80425-0048 is the product NDC for Naproxen, Naproxen 375 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, 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?
Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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 091416

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

FDA NDC Directory listings under ANDA 091416
ProductStrengthForm · routeLabelerProduct NDC
NaproxenNaproxen 250 mg/1TabletOralMARKSANS PHARMA LIMITED25000-138
NaproxenNaproxen 375 mg/1TabletOralMARKSANS PHARMA LIMITED25000-139
NaproxenNaproxen 500 mg/1TabletOralMARKSANS PHARMA LIMITED25000-140
NaproxenNaproxen 500 mg/1TabletOralQPharma Inc42708-140
NaproxenNaproxen 500 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-920
NaproxenNaproxen 375 mg/1TabletOralTIME CAP LABORATORIES49483-617
NaproxenNaproxen 500 mg/1TabletOralTIME CAP LABORATORIES49483-618
NaproxenNaproxen 250 mg/1TabletOralTIME CAP LABORATORIES49483-619
NaproxenNaproxen 500 mg/1TabletOralNorthwind Health Company, LLC51655-621
NaproxenNaproxen 500 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4006
NaproxenNaproxen 500 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4381
NaproxenNaproxen 250 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4510
NaproxenNaproxen 375 mg/1TabletOralBryant Ranch Prepack71335-0255
NaproxenNaproxen 250 mg/1TabletOralBryant Ranch Prepack71335-0973
NaproxenNaproxen 500 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-436
NaproxenNaproxen 500 mg/1TabletOralDIRECT RX72189-136
NaproxenNaproxen 500 mg/1TabletOralAsclemed USA, Inc.76420-042

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