Pilocarpine Hcl Powder
NDC Package 58574-001-01

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Pilocarpine Hcl powders is a medication used alone or with other medications to treat high pressure inside the eye due to glaucoma or other eye diseases (e.g., ocular hypertension). This formulation utilizes a powder delivery system. Marketed by Anidro Do Brasil Extracoes S.a., this product is identified by NDC 58574-001.

Identification & Billing

NDC Package Code
58574-001-01
Package Description
25 BAG in 1 DRUM / 1 kg in 1 BAG
Product Code
58574-001
11-Digit Billing Format
58574000101

Clinical Specifications

Proprietary Name
Pilocarpine Hcl
Non-Proprietary Name
Pilocarpine Hcl
Substance Name
Pilocarpine Hydrochloride
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
PILOCARPINE HYDROCHLORIDE 1 kg/kg
Usage Information
This medication is used alone or with other medications to treat high pressure inside the eye due to glaucoma or other eye diseases (e.g., ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness, vision loss, and nerve damage. This medication may also be used during certain eye surgeries and to reverse the effects of drugs used to enlarge the pupil (e.g., during an eye exam). Pilocarpine works by causing the pupil of the eye to shrink and decreasing the amount of fluid within the eye.

Regulatory & Marketing

Labeler Name
Anidro Do Brasil Extracoes S.a.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
09-12-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (58574-001). Click a package code to view its specific billing and regulatory data.

58574-001-02
1 BAG in 1 DRUM / 25 kg in 1 BAG

* 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 58574-001-01 identifies a specific commercial package of 25 bag in 1 drum / 1 kg in 1 bag of Pilocarpine Hcl (UNFINISHED drug), a bulk ingredient labeled by Anidro Do Brasil Extracoes S.a.. This powder is formulated for use and contains pilocarpine hydrochloride 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 Anidro Do Brasil Extracoes S.a. on September 12, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used alone or with other medications to treat high pressure inside the eye due to glaucoma or other eye diseases (e.g., ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness, vision loss, and nerve damage. This medication may also be used during certain eye surgeries and to reverse the effects of drugs used to enlarge the pupil (e.g., during an eye exam). Pilocarpine works by causing the pupil of the eye to shrink and decreasing the amount of fluid within the eye.

How is this Anidro Do Brasil Extracoes S.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58574000101. 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)
58574-001-01
11-Digit CMS (5-4-2)
58574-0001-01

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