What is NDC 0615-8094?

0615-8094 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, Inc dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.

NCS HealthCare of KY, Inc dba Vangard Labs, NDC labeler code 0615. 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 0615-8094 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8094Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8094Add 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
0615-8094-39	0061580943900615809439	30 TABLET in 1 BLISTER PACK (0615-8094-39)Marketed from Feb 18, 2010

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 500 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NCS HealthCare of KY, Inc dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075927
Marketing start: Feb 18, 2010
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 0615-8094_0aa460fe-3ac9-4b38-8e2b-8a59e5cb3563SPL ID 0aa460fe-3ac9-4b38-8e2b-8a59e5cb3563SPL set ID 62a12771-bde9-4bc3-9ce9-672c8e31f020RxCUI 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

N400615809439 followed by a unit qualifier and the quantity

Package 00615-8094-39. 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 Oct 12, 2017. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation) . Naproxen as naproxen 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 For relief of the signs and symptoms of tendonitis For re…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8094

What is NDC 0615-8094?: 0615-8094 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, Inc dba Vangard Labs. 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?: NCS HealthCare of KY, Inc dba Vangard Labs, NDC labeler code 0615. 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 075927

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

FDA NDC Directory listings under ANDA 075927
Product	Strength	Form · route	Labeler	Product NDC
Naproxen	Naproxen 500 mg/1	TabletOral	QPharma, Inc.	42708-043
Naproxen	Naproxen 250 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-600
Naproxen	Naproxen 375 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-650
Naproxen	Naproxen 375 mg/1	TabletOral	A-S Medication Solutions	50090-4636
Naproxen	Naproxen 375 mg/1	TabletOral	A-S Medication Solutions	50090-4637
Naproxen	Naproxen 375 mg/1	TabletOral	A-S Medication Solutions	50090-4638
Naproxen	Naproxen 250 mg/1	TabletOral	A-S Medication Solutions	50090-4752
Naproxen	Naproxen 250 mg/1	TabletOral	AvPAK	50268-594
Naproxen	Naproxen 375 mg/1	TabletOral	AvPAK	50268-595
Naproxen	Naproxen 500 mg/1	TabletOral	Northwind Health Company, LLC	51655-363
Naproxen	Naproxen 250 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-188
Naproxen	Naproxen 375 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-189
Naproxen	Naproxen 500 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-190
Naproxen	Naproxen 500 mg/1	TabletOral	Proficient Rx LP	63187-455
Naproxen	Naproxen 500 mg/1	TabletOral	Bryant Ranch Prepack	63629-5863
Naproxen	Naproxen 250 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-188
Naproxen	Naproxen 375 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-189
Naproxen	Naproxen 500 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-190
Naproxen	Naproxen 500 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7090
Naproxen	Naproxen 500 mg/1	TabletOral	Bryant Ranch Prepack	71335-0345

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