What is NDC 80425-0378?

80425-0378 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy 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?

185 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Naproxen NDC 80425-0378 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0378Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0378Add 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 NDC	11-digit (billing)	Package
80425-0378-1	80425037801	30 TABLET in 1 BOTTLE (80425-0378-1)Marketed from Mar 21, 2024
80425-0378-2	80425037802	60 TABLET in 1 BOTTLE (80425-0378-2)Marketed from Mar 21, 2024
80425-0378-3	80425037803	90 TABLET in 1 BOTTLE (80425-0378-3)Marketed from Mar 21, 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: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212517
Marketing start: Mar 21, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 80425-0378_14311237-54e9-3905-e063-6394a90adf53SPL ID 14311237-54e9-3905-e063-6394a90adf53SPL set ID 1431b769-5535-78d6-e063-6394a90a8423RxCUI 198014UNII 57Y76R9ATQ
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug

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

N480425037801 followed by a unit qualifier and the quantity

Package 80425-0378-01. 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 Mar 21, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

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 Naproxen 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 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 80425-0378

What is NDC 80425-0378?: 80425-0378 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 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?: Advanced Rx Pharmacy 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?: 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Naproxen	Naproxen 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-4750	70518-4750-00
Naproxen	Naproxen 500 mg/1	TabletOral	Coupler LLC	67046-0784	67046-0784-03
Naproxen	Naproxen 250 mg/1	TabletOral	Coupler LLC	67046-0499	67046-0499-03
Naproxen	Naproxen 375 mg/1	TabletOral	Coupler LLC	67046-0500	67046-0500-03
Naproxen	Naproxen 500 mg/1	TabletOral	Coupler LLC	67046-0501	67046-0501-03
Naproxen	Naproxen 375 mg/1	Tablet, Delayed releaseOral	Sunrise Pharmaceutical, Inc.	11534-211	11534-0211-01
Naproxen	Naproxen 500 mg/1	Tablet, Delayed releaseOral	Sunrise Pharmaceutical, Inc.	11534-212	11534-0212-01
Naproxen	Naproxen 250 mg/1	TabletOral	REMEDYREPACK INC.	70518-4514	70518-4514-00
Naproxen	Naproxen 500 mg/1	TabletOral	Medcore LLC	82461-711	82461-0711-60
Naproxen	Naproxen 125 mg/5mL	SuspensionOral	Aurobindo Pharma Limited	59651-528	59651-0528-47

All 186 Naproxen NDCs

Other NDCs under ANDA 212517

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

FDA NDC Directory listings under ANDA 212517
Product	Strength	Form · route	Labeler	Product NDC
Naproxen	Naproxen 375 mg/1	TabletOral	REMEDYREPACK INC.	70518-3486
Naproxen	Naproxen 500 mg/1	TabletOral	ScieGen Pharmaceuticals, Inc.	50228-436
Naproxen	Naproxen 375 mg/1	TabletOral	HAWAII REPACK, INC.	85534-0023
Naproxen	Naproxen 250 mg/1	TabletOral	ScieGen Pharmaceuticals, Inc.	50228-434
Naproxen	Naproxen 500 mg/1	TabletOral	HAWAII REPACK, INC.	85534-0024
Naproxen	Naproxen 375 mg/1	TabletOral	ScieGen Pharmaceuticals, Inc.	50228-435
Naproxen	Naproxen 500 mg/1	TabletOral	Northwind Health Company, LLC	51655-743
Naproxen	Naproxen 375 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0175
Naproxen	Naproxen 250 mg/1	TabletOral	HAWAII REPACK, INC.	85534-0058
Naproxen	Naproxen 250 mg/1	TabletOral	Radha Pharmaceuticals, Inc.	77771-434
Naproxen	Naproxen 375 mg/1	TabletOral	Radha Pharmaceuticals, Inc.	77771-435
Naproxen	Naproxen 500 mg/1	TabletOral	Radha Pharmaceuticals, Inc.	77771-436
Naproxen	Naproxen 500 mg/1	TabletOral	Quality Care Products, LLC	55700-888
Naproxen	Naproxen 500 mg/1	TabletOral	Asclemed USA, Inc.	76420-264
Naproxen	Naproxen 500 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-564
Naproxen	Naproxen 375 mg/1	TabletOral	Preferred Pharmaceuticals, Inc.	68788-7946
Naproxen	Naproxen 500 mg/1	TabletOral	Medcore LLC	82461-711
Naproxen	Naproxen 375 mg/1	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-644
Naproxen	Naproxen 500 mg/1	TabletOral	Proficient Rx LP	71205-597
Naproxen	Naproxen 375 mg/1	TabletOral	Medsource Pharmaceuticals	45865-238

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