What is NDC 49483-618?

49483-618 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by TIME CAP LABORATORIES. It has 2 package NDCs, shown above in 10- and 11-digit form.

TIME CAP LABORATORIES, NDC labeler code 49483. 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?

184 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 49483-618 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)49483-618Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49483-0618Add 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
49483-618-01	49483061801	100 TABLET in 1 BOTTLE, PLASTIC (49483-618-01)Marketed from Jul 6, 2016
49483-618-50	49483061850	500 TABLET in 1 BOTTLE, PLASTIC (49483-618-50)Marketed from Jul 6, 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: TIME CAP LABORATORIESNDC labeler code 49483
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091416
Marketing start: Jul 6, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 49483-618_77d2030d-4699-2117-e053-2a91aa0a6dc8SPL ID 77d2030d-4699-2117-e053-2a91aa0a6dc8SPL set ID 4350a2d9-5228-460e-b7b1-27e8fa846787RxCUI 198012, 198013, 198014UNII 57Y76R9ATQUPC 0349483617016, 0349483618013, 0349483619010
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

N449483061801 followed by a unit qualifier and the quantity

Package 49483-0618-01. 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 Oct 9, 2018.

Indications (excerpt from the label)

CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISKS OF NAPROXEN AND OTHER TREATMENT OPTIONS BEFORE DECIDING TO USE NAPROXEN TABLETS. USE THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH INDIVIDUAL PATIENT TREATMENT GOALS (SEE WARNINGS: GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). 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 NAPROXEN TABLETS ARE ALSO INDICATED: FOR RELIEF OF THE SIGNS AND SYMPTOMS OF TENDONITIS FOR RELIEF OF…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49483-618

What is NDC 49483-618?: 49483-618 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by TIME CAP LABORATORIES. 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?: TIME CAP LABORATORIES, NDC labeler code 49483. 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?: 184 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 185 Naproxen NDCs

Other NDCs under ANDA 091416

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

FDA NDC Directory listings under ANDA 091416
Product	Strength	Form · route	Labeler	Product NDC
Naproxen	Naproxen 250 mg/1	TabletOral	MARKSANS PHARMA LIMITED	25000-138
Naproxen	Naproxen 375 mg/1	TabletOral	MARKSANS PHARMA LIMITED	25000-139
Naproxen	Naproxen 500 mg/1	TabletOral	MARKSANS PHARMA LIMITED	25000-140
Naproxen	Naproxen 500 mg/1	TabletOral	QPharma Inc	42708-140
Naproxen	Naproxen 500 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-920
Naproxen	Naproxen 375 mg/1	TabletOral	TIME CAP LABORATORIES	49483-617
Naproxen	Naproxen 250 mg/1	TabletOral	TIME CAP LABORATORIES	49483-619
Naproxen	Naproxen 500 mg/1	TabletOral	Northwind Health Company, LLC	51655-621
Naproxen	Naproxen 500 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4006
Naproxen	Naproxen 500 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4381
Naproxen	Naproxen 250 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4510
Naproxen	Naproxen 375 mg/1	TabletOral	Bryant Ranch Prepack	71335-0255
Naproxen	Naproxen 250 mg/1	TabletOral	Bryant Ranch Prepack	71335-0973
Naproxen	Naproxen 500 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-436
Naproxen	Naproxen 500 mg/1	TabletOral	DIRECT RX	72189-136
Naproxen	Naproxen 500 mg/1	TabletOral	Asclemed USA, Inc.	76420-042
Naproxen	Naproxen 375 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0048