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U.S. Department of Health and Human Services

FDA Drug Shortages

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Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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 Methylphenidate Hydrochloride Tablets

 Status: Currently in Shortage

 » Date first reported: 02/19/2013
 » Therapeutic Categories: Pediatric; Psychiatry

Actavis, Inc. (Revised 09/23/2014)

Company Contact Information:
800-272-5525

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Methylphenidate Hydrochloride Tablets, USP, 5 mg (NDC 0591-5882-01) Available Other
Methylphenidate Hydrochloride Tablets, USP, 10 mg (NDC 0591-5883-01) Available Other

CorePharma (New 07/18/2014)

Company Contact Information:
800-850-2719

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Methylphenidate Hydrochloride Tablets, USP, 5 mg (NDC 64720-237-10) Available No supply issues anticipated Other
Methylphenidate Hydrochloride Tablets, USP, 20 mg (NDC 64720-239-10) Available No supply issues anticipated Other
Methylphenidate Hydrochloride Tablets, USP, 10 mg (NDC 64720-238-10) Available No supply issues anticipated Other

Mallinckrodt (Revised 09/24/2014)

Company Contact Information:
800-325-8888

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
5 mg IR tablets (NDC 00406-1142-10) 1000 package size Available Shortage per Manufacturer: Available Product available
10 mg IR tablets (NDC 00406-1144-01 and 00406-1144-10) 1000 package size Available Product available
20 mg IR tablets (NDC 00406-1146-01 and 00406-1146-10) 1000 package size Available Shortage per Manufacturer: Available Product available

Sandoz (Revised 09/29/2014)

Company Contact Information:
609-627-8500

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
5 mg, 100s (NDC 00781-5748-01) This is currently on backorder . API needs to be requalified. Additional product won't be avail until end of September or early October 2014. Manufacturing site capacity and API qualification Other
10 mg, 100s (NDC 00781-5749-01) This is currently on backorder . API needs to be requalified. Additional product won't be avail until end of September or early October 2014. Manufacturing site capacity and API qualification Shortage of an active ingredient
20 mg, 100s (NDC 00781-5753-01) This is currently on backorder.API needs to be requalified. Additional product won't be avail until mid October 2014. Manufacturing site capacity and API qualification Shortage of an active ingredient

UCB Inc. (Revised 09/29/2014)

Company Contact Information:
800-477-7877

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Methylphenidate Hydrochloride Tablets Immediate Release, USP 20 mg, 100s (NDC 53014-532-07) Available Shortage per Manufacturer: Available Other
Methylphenidate Hydrochloride Tablets Immediate Release USP 10 mg, 100s (NDC 53014-530-07) Available Shortage per Manufacturer: Available Other
Methylphenidate Hydrochloride Immediate Release Tablets, USP 5mg, 100s (NDC 53014-531-07) Available Shortage per Manufacturer: Available Other
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