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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 01/13/2014)

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 No supply issues anticipated Other
Methylphenidate Hydrochloride Tablets, USP, 10 mg (NDC 0591-5883-01) Available No supply issues anticipated Other
Methylphenidate Hydrochloride Tablets, USP, 20 mg (NDC 0591-5882-01) Available No supply issues anticipated 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 (Reverified 09/16/2014)

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 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 Product available

Sandoz (Revised 09/11/2014)

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 available until early September 2014. Manufacturing site capacity 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 available until early September 2014. Manufacturing site capacity 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 API qualification Shortage of an active ingredient

UCB Inc. (Reverified 09/10/2014)

Company Contact Information:
800-477-7877

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
20 mg Methylphenidate Hydrochloride IR tablets, 100s (NDC 53014-532-07 Available Demand increase for the drug
10 mg Methylphenidate Immediate Release Tablets - 100 Tabs(NDC 53014-530-07) Available Demand increase for the drug
5 mg Methylphenidate IR tablets- 100 tabs (NDC 53014-0531-07) Available Demand increase for the drug
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