Vitapirena Granule, For Solution
NDC Package 55758-012-05

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

Package Information

Vitapirena (acetaminophen) granules is a medication used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever. This formulation utilizes a granule, for solution delivery system. Marketed by Pharmadel Llc, this product is identified by NDC 55758-012 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
55758-012-05
Package Description
5 PACKET in 1 BOX / 1 GRANULE, FOR SOLUTION in 1 PACKET
Product Code
55758-012
11-Digit Billing Format
55758001205
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vitapirena
Non-Proprietary Name
Acetaminophen
Substance Name
Acetaminophen
Dosage Form
Granule, For Solution - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ACETAMINOPHEN 500 mg/1
Usage Information
This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

Regulatory & Marketing

Labeler Name
Pharmadel Llc
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-25-2023
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 55758-012-05 identifies a specific commercial package of 5 packet in 1 box / 1 granule, for solution in 1 packet of Vitapirena, a human over the counter drug labeled by Pharmadel Llc. This granule, for solution is formulated for oral use and contains acetaminophen 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 Pharmadel Llc on October 25, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

How is this Pharmadel Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55758001205. 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)
55758-012-05
11-Digit CMS (5-4-2)
55758-0012-05

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