Pilocarpine Hydrochloride Ophthalmic Solution/ Drops
NDC Package 60219-2649-1

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

Package Information

Pilocarpine Hydrochloride Ophthalmic (pilocarpine hydrochloride) solution/ dropses is pilocarpine hydrochloride ophthalmic solution is indicated for the treatment of presbyopia in adults. This formulation utilizes a solution/ drops delivery system. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 60219-2649 and is authorized under FDA application ANDA217733.

Identification & Billing

NDC Package Code
60219-2649-1
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER
Product Code
60219-2649
11-Digit Billing Format
60219264901
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pilocarpine Hydrochloride Ophthalmic
Non-Proprietary Name
Pilocarpine Hydrochloride
Substance Name
Pilocarpine Hydrochloride
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
PILOCARPINE HYDROCHLORIDE 12.5 mg/mL
Pharmacologic Class
Usage Information
Pilocarpine hydrochloride ophthalmic solution is indicated for the treatment of presbyopia in adults.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Ny Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA217733
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-2025
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 60219-2649-1 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper of Pilocarpine Hydrochloride Ophthalmic, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. This solution/ drops is formulated for ophthalmic 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 Amneal Pharmaceuticals Ny Llc on September 01, 2025. The current certification is valid through December 31, 2026.

How is this Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60219264901. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-4-1)
60219-2649-1
11-Digit CMS (5-4-2)
60219-2649-01

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