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Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Methylphenidate Hydrochloride Tablet, Extended Release
Status: Currently in Shortage
»Date first posted: 07/26/2023
»Therapeutic Categories: Psychiatry

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Dr. Reddy's Laboratories, Inc. (Reverified 07/01/2024)

Company Contact Information:
866-732-3952

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Tablet, Extended Release, 18 mg (NDC 43598-438-01) Unavailable Unavailable. Estimated limited supplies from July 2024 Other
Tablet, Extended Release, 27 mg (NDC 43598-439-01) Unavailable Unavailable. Estimated limited supplies from July 2024 Other
Tablet, Extended Release, 36 mg (NDC 43598-440-01) Unavailable Unavailable. Estimated limited supplies from July 2024 Other
Tablet, Extended Release, 54 mg (NDC 43598-441-01) Unavailable Unavailable. Estimated limited supplies from July 2024 Other

Janssen Pharmaceuticals (Reverified 07/17/2024)

Company Contact Information:
800-JANSSEN (1-800-526-7736) Monday through Friday from 9:00 AM to 8:00 PM ET

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Concerta, Tablet, Extended Release, 18 mg (NDC 50458-585-01) Available
Concerta, Tablet, Extended Release, 27 mg (NDC 50458-588-01) Available
Concerta, Tablet, Extended Release, 36 mg (NDC 50458-586-01) Available
Concerta, Tablet, Extended Release, 54 mg (NDC 50458-587-01) Available

Lannett Company, Inc. (Reverified 07/15/2024)

Company Contact Information:
844-834-0530

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Tablet, Extended Release, 18 mg (NDC 62175-310-37) Limited Availability Allocating limited inventory Demand increase for the drug
Tablet, Extended Release, 27 mg (NDC 62175-311-37) Limited Availability Shortage of an active ingredient
Tablet, Extended Release, 36 mg (NDC 62175-312-37) Limited Availability Shortage of an active ingredient
Tablet, Extended Release, 54 mg (NDC 62175-313-37) Limited Availability Shortage of an active ingredient

SpecGx LLC (Revised 07/15/2024)

Company Contact Information:
800-325-8888

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Methylin Er, Tablet, Extended Release, 10 mg (NDC 0406-1445-01) Limited Availability Allocations to all customers. Backorder projected Sept. Shortage of an active ingredient
Methylin Er, Tablet, Extended Release, 20 mg (NDC 0406-1473-01) Limited Availability Allocation to all customers; Expected backorder late Sept. Shortage of an active ingredient
Tablet, Extended Release, 27 mg (NDC 0406-0127-01) Unavailable Backorder. Next release mid Aug. Intermittent backorder projected through Oct. Shortage of an active ingredient
Tablet, Extended Release, 36 mg (NDC 0406-0136-01) Limited Availability Allocations to all customers. Stockout expected July. Next release mid Aug. Intermittent backorder projected through Oct. Shortage of an active ingredient
Tablet, Extended Release, 54 mg (NDC 0406-0154-01) Limited Availability Allocations primary customers. Stockout expected July. Next release late Aug. Intermittent backorder projected through Oct. Shortage of an active ingredient

Sun Pharmaceutical Industries, Inc. (Revised 07/08/2024)

Company Contact Information:
800-818-4555

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Methylphenidate Hydrochloride, Tablet, Extended Release, 18 mg (NDC 57664-606-88) Unavailable Shortage of an active ingredient
Methylphenidate Hydrochloride, Tablet, Extended Release, 27 mg (NDC 57664-607-88) Unavailable Shortage of an active ingredient
Methylphenidate Hydrochloride, Tablet, Extended Release, 36 mg (NDC 57664-608-88) Unavailable Currently Not Marketed Discontinuation of the manufacture of the drug
Methylphenidate Hydrochloride, Tablet, Extended Release, 54 mg (NDC 57664-609-88) Unavailable Currently Not Marketed Discontinuation of the manufacture of the drug

Teva Pharmaceuticals USA, Inc. (Revised 07/19/2024)

Company Contact Information:
800-545-8800

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Methylphenidate Hydrochloride Extended-Release Tablets, USP CII, Tablet, Extended Release, 18 mg (NDC 62037-725-01) Available -
Methylphenidate Hydrochloride Extended-Release Tablets, USP CII, Tablet, Extended Release, 27 mg (NDC 62037-734-01) Limited Availability Estimated recovery July 2024 Demand increase for the drug
Methylphenidate Hydrochloride Extended-Release Tablets, USP CII, Tablet, Extended Release, 36 mg (NDC 62037-726-01) Available Estimated recovery 'Oct 2024 Demand increase for the drug
Methylphenidate Hydrochloride Extended-Release Tablets, USP CII, Tablet, Extended Release, 54 mg (NDC 62037-727-01) Limited Availability Estimated recovery 'Oct 2024 Other

Trigen Laboratories, LLC (Revised 03/07/2024)

Company Contact Information:
800-541-4802

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Methylphenidate Hydrochloride, Tablet, Extended Release, 18 mg (NDC 13811-706-10) Available Allocation to current contracted customers Demand increase for the drug
Methylphenidate Hydrochloride, Tablet, Extended Release, 27 mg (NDC 13811-707-10) Available Allocation to current contracted customers Demand increase for the drug
Methylphenidate Hydrochloride, Tablet, Extended Release, 36 mg (NDC 13811-708-10) Available Allocation to current contracted customers Demand increase for the drug
Methylphenidate Hydrochloride, Tablet, Extended Release, 45 mg (NDC 13811-711-30) Available
Methylphenidate Hydrochloride, Tablet, Extended Release, 54 mg (NDC 13811-709-10) Available Allocation to current contracted customers Demand increase for the drug
Methylphenidate Hydrochloride, Tablet, Extended Release, 63 mg (NDC 13811-700-30) Available
Methylphenidate Hydrochloride, Tablet, Extended Release, 72 mg (NDC 13811-710-30) Available

Vertical Pharmaceuticals, LLC (Reverified 07/15/2024)

Company Contact Information:
800-541-4802

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Relexxii, Tablet, Extended Release, 18 mg (NDC 68025-095-10) Available
Relexxii, Tablet, Extended Release, 27 mg (NDC 68025-096-10) Available
Relexxii, Tablet, Extended Release, 36 mg (NDC 68025-097-10) Available
Relexxii, Tablet, Extended Release, 45 mg (NDC 68025-088-30) Available
Relexxii, Tablet, Extended Release, 54 mg (NDC 68025-098-10) Available
Relexxii, Tablet, Extended Release, 63 mg (NDC 68025-089-30) Available
Relexxii, Tablet, Extended Release, 72 mg (NDC 68025-084-30) Available
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