Ibuprofen Mini Capsule, Liquid Filled
NDC Package 53345-050-01

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

Package Information

Ibuprofen Mini capsules is ibuprofen is used to help relieve mild to moderate pain. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd, this product is identified by NDC 53345-050 and is authorized under FDA application ANDA206568.

Identification & Billing

NDC Package Code
53345-050-01
Package Description
1 BAG in 1 BOX / 12000 CAPSULE, LIQUID FILLED in 1 BAG
Product Code
53345-050
11-Digit Billing Format
53345005001
RxNorm Crosswalk
RxCUI: 310964 - ibuprofen 200 MG Oral Capsule

Clinical Specifications

Proprietary Name
Ibuprofen Mini
Non-Proprietary Name
Ibuprofen Mini
Substance Name
Ibuprofen
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)
IBUPROFEN 200 mg/1
Pharmacologic Class
Usage Information
Ibuprofen is used to help relieve mild to moderate pain. When used with an opioid (such as morphine), it may be used to relieve moderate to severe pain. It is also used to reduce fever. Ibuprofen is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

Regulatory & Marketing

Labeler Name
Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd
Product Type
Human Otc Drug
FDA Application #
ANDA206568
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-20-2018
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 53345-050-01 identifies a specific commercial package of 1 bag in 1 box / 12000 capsule, liquid filled in 1 bag of Ibuprofen Mini, a human over the counter drug labeled by Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd. This capsule, liquid filled is formulated for oral use and contains ibuprofen 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 Pharmaceutical (wuhan) Co., Ltd on November 20, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ibuprofen is used to help relieve mild to moderate pain. When used with an opioid (such as morphine), it may be used to relieve moderate to severe pain. It is also used to reduce fever. Ibuprofen is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53345005001. 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)
53345-050-01
11-Digit CMS (5-4-2)
53345-0050-01

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