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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 (Reverified 10/21/2014)

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 10/15/2014)

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) Currently off of backorder. Manufacturing site capacity and API qualification Other
10 mg, 100s (NDC 00781-5749-01) Currently has very small backorder. Expecting delivery 10/17/2014. May have short term backorders due to available API through 2014. Manufacturing site capacity & API availablilty Shortage of an active ingredient
20 mg, 100s (NDC 00781-5753-01) This is currently on backorder.API needs to be requalified. Expecting delivery 10/17/2014. May have short term backorders due to available API through 2014. Manufacturing site capacity & API availablilty Shortage of an active ingredient

UCB Inc. (Reverified 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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