Naproxen Sodium Capsule, Liquid Filled
NDC Package 53345-042-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Naproxen Sodium capsules is see also Warning section. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Humanwell Puracap Pharmaceuticals (wuhan) Co., Ltd, this product is identified by NDC 53345-042 and is authorized under FDA application ANDA208363.

Identification & Billing

NDC Package Code
53345-042-01
Package Description
1 BAG in 1 BOX / 5000 CAPSULE, LIQUID FILLED in 1 BAG
Product Code
53345-042
11-Digit Billing Format
53345004201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Naproxen Sodium
Non-Proprietary Name
Naproxen Sodium
Substance Name
Naproxen Sodium
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NAPROXEN SODIUM 220 mg/1
Pharmacologic Class
Usage Information
See also Warning section. Naproxen is used to relieve pain from various conditions such as headache, muscle aches, tendonitis, dental pain, and menstrual cramps. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Regulatory & Marketing

Labeler Name
Humanwell Puracap Pharmaceuticals (wuhan) Co., Ltd
Product Type
Human Otc Drug
FDA Application #
ANDA208363
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-20-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53345-042-01 identifies a specific commercial package of 1 bag in 1 box / 5000 capsule, liquid filled in 1 bag of Naproxen Sodium, a human over the counter drug labeled by Humanwell Puracap Pharmaceuticals (wuhan) Co., Ltd. This capsule, liquid filled is formulated for oral use and contains naproxen sodium as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Humanwell Puracap Pharmaceuticals (wuhan) Co., Ltd on March 20, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

See also Warning section. Naproxen is used to relieve pain from various conditions such as headache, muscle aches, tendonitis, dental pain, and menstrual cramps. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

How is this Humanwell Puracap Pharmaceuticals (wuhan) Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53345004201. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
53345-042-01
11-Digit CMS (5-4-2)
53345-0042-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.