What is NDC 76282-342?

76282-342 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by Exelan Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Exelan Pharmaceuticals, Inc., NDC labeler code 76282. 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 76282-342 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76282-342Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76282-0342Add 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
76282-342-01	7628203420176282034201	100 TABLET in 1 BOTTLE (76282-342-01)Marketed from Jun 10, 2016
76282-342-05	7628203420576282034205	500 TABLET in 1 BOTTLE (76282-342-05)Marketed from Jun 10, 2016

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 — 500 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Exelan Pharmaceuticals, Inc.NDC labeler code 76282
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091305
Marketing start: Jun 10, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 76282-342_509fffe2-2bab-4ae4-8c53-520e1c5eff68SPL ID 509fffe2-2bab-4ae4-8c53-520e1c5eff68SPL set ID 46dbdb95-a0d0-4410-8d64-b22763b12af7RxCUI 198012, 198013, 198014UNII 57Y76R9ATQUPC 0376282341019, 0376282340012, 0376282342016
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

N476282034201 followed by a unit qualifier and the quantity

Package 76282-0342-01. 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 Aug 17, 2020. 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 Naproxen tablets are also indicated for: the relief of signs and symptoms of: 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 Naproxen tablets are also indicated for: the relief of signs and symptoms of: tendonitis bursitis acute gout the management of: pain primary dysmeno…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76282-342

What is NDC 76282-342?: 76282-342 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by Exelan Pharmaceuticals, Inc.. It has 2 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?: Exelan Pharmaceuticals, Inc., NDC labeler code 76282. 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 091305

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

FDA NDC Directory listings under ANDA 091305
Product	Strength	Form · route	Labeler	Product NDC
Naproxen	Naproxen 500 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	43353-211
Naproxen	Naproxen 250 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	43353-216
Naproxen	Naproxen 375 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	43353-218
naproxen	Naproxen 250 mg/1	TabletOral	Cipla USA Inc.	69097-853
naproxen	Naproxen 375 mg/1	TabletOral	Cipla USA Inc.	69097-854
naproxen	Naproxen 500 mg/1	TabletOral	Cipla USA Inc.	69097-855
Naproxen	Naproxen 250 mg/1	TabletOral	Exelan Pharmaceuticals, Inc.	76282-340
Naproxen	Naproxen 375 mg/1	TabletOral	Exelan Pharmaceuticals, Inc.	76282-341