What is NDC 68462-189?

68462-189 is the product NDC for Naproxen, Naproxen 375 mg/1 tablet, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 2 package NDCs, shown above in 10- and 11-digit form.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 68462-189 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-189Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0189Add 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
68462-189-01	68462018901	100 TABLET in 1 BOTTLE (68462-189-01)Marketed from Jul 1, 2007
68462-189-05	68462018905	500 TABLET in 1 BOTTLE (68462-189-05)Marketed from Jul 1, 2007

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: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078250
Marketing start: Jul 1, 2007
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 68462-189_16372549-a419-4920-a200-5128017570edSPL ID 16372549-a419-4920-a200-5128017570edSPL set ID 6c5bb008-e66f-4ef0-bf84-aca7eb5983e9RxCUI 198012, 198013, 198014, 849398, 849431UNII 57Y76R9ATQ, 9TN87S3A3CUPC 0368462189016, 0368462178010, 0368462179017, 0368462188019, 0368462190012
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

N468462018901 followed by a unit qualifier and the quantity

Package 68462-0189-01. 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 Dec 23, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets and naproxen sodium tablets are also indicated for: the relief of signs and symptoms of: • tendonitis • bursitis • acute gout the management of: • pain • primary dysmenorrhea Naproxen tablets and naproxen sodium 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 and naproxen sodium t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-189

What is NDC 68462-189?: 68462-189 is the product NDC for Naproxen, Naproxen 375 mg/1 tablet, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. 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?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 078250

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

FDA NDC Directory listings under ANDA 078250
Product	Strength	Form · route	Labeler	Product NDC
Naproxen	Naproxen 375 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8844
Naproxen	Naproxen 250 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-188
Naproxen	Naproxen 500 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-190
Naproxen	Naproxen 500 mg/1	TabletOral	A-S Medication Solutions	50090-7198
Naproxen	Naproxen 500 mg/1	TabletOral	Bryant Ranch Prepack	71335-2485
Naproxen	Naproxen 250 mg/1	TabletOral	Proficient Rx LP	63187-461
Naproxen	Naproxen 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-1516
Naproxen	Naproxen 500 mg/1	TabletOral	Proficient Rx LP	63187-028
Naproxen	Naproxen 375 mg/1	TabletOral	Bryant Ranch Prepack	71335-0095
Naproxen	Naproxen 375 mg/1	TabletOral	Proficient Rx LP	63187-535
Naproxen	Naproxen 500 mg/1	TabletOral	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	83209-190
Naproxen	Naproxen 250 mg/1	TabletOral	Bryant Ranch Prepack	71335-0217
Naproxen	Naproxen 375 mg/1	TabletOral	A-S Medication Solutions	50090-1584
Naproxen	Naproxen 375 mg/1	TabletOral	A-S Medication Solutions	50090-1583
Naproxen	Naproxen 250 mg/1	TabletOral	A-S Medication Solutions	50090-2788
Naproxen	Naproxen 500 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	66267-153
Naproxen	Naproxen 375 mg/1	TabletOral	A-S Medication Solutions	50090-1585
Naproxen	Naproxen 500 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	66267-807
Naproxen	Naproxen 500 mg/1	TabletOral	A-S Medication Solutions	50090-0481
Naproxen	Naproxen 500 mg/1	TabletOral	A-S Medication Solutions	50090-0482

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