Drugplain

Pilocarpine Hydrochloride Ophthalmic 12.5 mg/mL

Pilocarpine Hydrochloride · SOLUTION/ DROPS · Amneal Pharmaceuticals NY LLC

4 Recalls on RecordCurrently in Shortage
Plain English

Pilocarpine Hydrochloride Ophthalmic is a solution/ drops containing pilocarpine hydrochloride at 12.5 mg/mL, taken ophthalmic. Manufactured by Amneal Pharmaceuticals NY LLC.

Key Facts

Brand Name
Pilocarpine Hydrochloride Ophthalmic
Generic Name
Pilocarpine Hydrochloride
NDC Code (Product)
60219-2649
Manufacturer
Amneal Pharmaceuticals NY LLC
Strength
12.5 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
ANDA217733
Marketing Start
09/01/2025

Recall History

4 Recalls on Record
Class II04/26/2023

Akorn, Inc.

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

OngoingVoluntary: Firm initiated
Class II04/26/2023

Akorn, Inc.

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

OngoingVoluntary: Firm initiated
Class II04/26/2023

Akorn, Inc.

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

OngoingVoluntary: Firm initiated
Class III03/22/2017

Novartis Pharmaceuticals Corp.

Failed Impurities/Degradation Specifications.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is Pilocarpine Hydrochloride Ophthalmic used for?

Pilocarpine Hydrochloride Ophthalmic contains Pilocarpine Hydrochloride. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Pilocarpine Hydrochloride Ophthalmic a controlled substance?

Pilocarpine Hydrochloride Ophthalmic is not classified as a controlled substance by the DEA.

What is the generic name for Pilocarpine Hydrochloride Ophthalmic?

The generic name for Pilocarpine Hydrochloride Ophthalmic is Pilocarpine Hydrochloride. There are 10 other brand versions of Pilocarpine Hydrochloride.

What is the NDC code for Pilocarpine Hydrochloride Ophthalmic 12.5 mg/mL?

The NDC (National Drug Code) for Pilocarpine Hydrochloride Ophthalmic 12.5 mg/mL is 60219-2649, listed by Amneal Pharmaceuticals NY LLC.