What is NDC 45865-238?

45865-238 is the product NDC for Naproxen, Naproxen 375 mg/1 tablet, listed with the FDA by Medsource Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.

Medsource Pharmaceuticals, NDC labeler code 45865. 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?

189 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 45865-238 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)45865-238Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45865-0238Add 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	Copy
45865-238-60	4586502386045865023860	60 TABLET in 1 BOTTLE (45865-238-60)Marketed from Mar 1, 2020

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: Medsource PharmaceuticalsNDC labeler code 45865
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212517
Marketing start: Mar 1, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 45865-238_12648511-1b01-aaf8-e063-6394a90a2297SPL ID 12648511-1b01-aaf8-e063-6394a90a2297SPL set ID 12648efc-3be8-a915-e063-6394a90a3620RxCUI 198012UNII 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

N445865023860 followed by a unit qualifier and the quantity

Package 45865-0238-60. 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 Feb 27, 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 45865-238

What is NDC 45865-238?: 45865-238 is the product NDC for Naproxen, Naproxen 375 mg/1 tablet, listed with the FDA by Medsource Pharmaceuticals. 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?: Medsource Pharmaceuticals, NDC labeler code 45865. 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?: 189 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	Unit Dose Solutions, Inc.	87441-092	87441-0092-01
Naproxen	Naproxen 500 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-190	60760-0190-60
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

All 190 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 500 mg/1	TabletOral	A-S Medication Solutions	50090-5645
Naproxen	Naproxen 500 mg/1	TabletOral	A-S Medication Solutions	50090-5646
Naproxen	Naproxen 500 mg/1	TabletOral	A-S Medication Solutions	50090-5649
Naproxen	Naproxen 500 mg/1	TabletOral	A-S Medication Solutions	50090-7676
Naproxen	Naproxen 375 mg/1	TabletOral	A-S Medication Solutions	50090-8102
Naproxen	Naproxen 375 mg/1	TabletOral	A-S Medication Solutions	50090-8103
Naproxen	Naproxen 250 mg/1	TabletOral	ScieGen Pharmaceuticals, Inc.	50228-434
Naproxen	Naproxen 375 mg/1	TabletOral	ScieGen Pharmaceuticals, Inc.	50228-435
Naproxen	Naproxen 500 mg/1	TabletOral	ScieGen Pharmaceuticals, Inc.	50228-436
Naproxen	Naproxen 375 mg/1	TabletOral	Northwind Health Company, LLC	51655-657
Naproxen	Naproxen 500 mg/1	TabletOral	Northwind Health Company, LLC	51655-743
Naproxen	Naproxen 500 mg/1	TabletOral	Quality Care Products, LLC	55700-888
Naproxen	Naproxen 500 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-564
Naproxen	Naproxen 375 mg/1	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-644
Naproxen	Naproxen 250 mg/1	TabletOral	Bryant Ranch Prepack	63629-8511
Naproxen	Naproxen 375 mg/1	TabletOral	Bryant Ranch Prepack	63629-8512
Naproxen	Naproxen 375 mg/1	TabletOral	Bryant Ranch Prepack	63629-8513
Naproxen	Naproxen 500 mg/1	TabletOral	Bryant Ranch Prepack	63629-8514
Naproxen	Naproxen 500 mg/1	TabletOral	Bryant Ranch Prepack	63629-8515
Naproxen	Naproxen 500 mg/1	TabletOral	Coupler LLC	67046-0784

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