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7/1/2024

Amphetamine Extended-Release Oral Presentations

Products Affected - Description

    • Amphetamine mixed salts extended release capsule, Amneal, 10 mg, bottle, 100 count, NDC 00115-1487-01
    • Amphetamine mixed salts extended release capsule, Amneal, 15 mg, bottle, 100 count, NDC 00115-1488-01
    • Amphetamine mixed salts extended release capsule, Amneal, 20 mg, bottle, 100 count, NDC 00115-1489-01
    • Amphetamine mixed salts extended release capsule, Amneal, 25 mg, bottle, 100 count, NDC 00115-1490-01
    • Amphetamine mixed salts extended release capsule, Amneal, 30 mg, bottle, 100 count, NDC 00115-1491-01
    • Amphetamine mixed salts extended release capsule, Amneal, 5 mg, bottle, 100 count, NDC 00115-1486-01
    • Amphetamine mixed salts extended release capsule, Camber, 10 mg, bottle, 100 count, NDC 31722-0186-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Camber, 15 mg, bottle, 100 count, NDC 31722-0187-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Camber, 20 mg, bottle, 100 count, NDC 31722-0188-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Camber, 25 mg, bottle, 100 count, NDC 31722-0189-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Camber, 30 mg, bottle, 100 count, NDC 31722-0195-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Camber, 5 mg, bottle, 100 count, NDC 31722-0185-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Lannett, 10 mg, bottle, 100 count, NDC 00527-0791-37
    • Amphetamine mixed salts extended release capsule, Lannett, 15 mg, bottle, 100 count, NDC 00527-1488-37
    • Amphetamine mixed salts extended release capsule, Lannett, 20 mg, bottle, 100 count, NDC 00527-0793-37
    • Amphetamine mixed salts extended release capsule, Lannett, 25 mg, bottle, 100 count, NDC 00527-5514-37 - discontinued
    • Amphetamine mixed salts extended release capsule, Lannett, 30 mg, bottle, 100 count, NDC 00527-0795-37
    • Amphetamine mixed salts extended release capsule, Lannett, 5 mg, bottle, 100 count, NDC 00527-0790-37
    • Amphetamine mixed salts extended release capsule, Par Pharmaceuticals, 10 mg, bottle, 100 count, NDC 49884-0840-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Par Pharmaceuticals, 15 mg, bottle, 100 count, NDC 49884-0841-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Par Pharmaceuticals, 20 mg, bottle, 100 count, NDC 49884-0842-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Par Pharmaceuticals, 25 mg, bottle, 100 count, NDC 49884-0843-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Par Pharmaceuticals, 30 mg, bottle, 100 count, NDC 49884-0844-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Par Pharmaceuticals, 5 mg, bottle, 100 count, NDC 49884-0839-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Prasco, 10 mg, bottle, 100 count, NDC 66993-0595-02 - discontinued
    • Amphetamine mixed salts extended release capsule, Prasco, 15 mg, bottle, 100 count, NDC 66993-0596-02 - discontinued
    • Amphetamine mixed salts extended release capsule, Prasco, 20 mg, bottle, 100 count, NDC 66993-0597-02 - discontinued
    • Amphetamine mixed salts extended release capsule, Prasco, 25 mg, bottle, 100 count, NDC 66993-0598-02 - discontinued
    • Amphetamine mixed salts extended release capsule, Prasco, 30 mg, bottle, 100 count, NDC 66993-0599-02 - discontinued
    • Amphetamine mixed salts extended release capsule, Prasco, 5 mg, bottle, 100 count, NDC 66993-0594-02 - discontinued
    • Amphetamine mixed salts extended release capsule, Rhodes, 10 mg, bottle, 100 count, NDC 42858-0610-10
    • Amphetamine mixed salts extended release capsule, Rhodes, 15 mg, bottle, 100 count, NDC 42858-0215-01
    • Amphetamine mixed salts extended release capsule, Rhodes, 20 mg, bottle, 100 count, NDC 42858-0720-01
    • Amphetamine mixed salts extended release capsule, Rhodes, 25 mg, bottle, 100 count, NDC 42858-0325-01
    • Amphetamine mixed salts extended release capsule, Rhodes, 30 mg, bottle, 100 count, NDC 42858-0930-01
    • Amphetamine mixed salts extended release capsule, Rhodes, 5 mg, bottle, 100 count, NDC 42858-0055-01
    • Amphetamine mixed salts extended release capsule, Sandoz, 10 mg, bottle, 100 count, NDC 00781-2335-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Sandoz, 15 mg, bottle, 100 count, NDC 00781-2343-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Sandoz, 20 mg, bottle, 100 count, NDC 00781-2352-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Sandoz, 25 mg, bottle, 100 count, NDC 00781-2368-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Sandoz, 30 mg, bottle, 100 count, NDC 00781-2371-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Sandoz, 5 mg, bottle, 100 count, NDC 00781-2329-01 - discontinued
    • Amphetamine mixed salts extended release capsule, Sun Pharma, 10 mg, bottle, 100 count, NDC 57664-0337-88 - discontinued
    • Amphetamine mixed salts extended release capsule, Sun Pharma, 15 mg, bottle, 100 count, NDC 57664-0338-88 - discontinued
    • Amphetamine mixed salts extended release capsule, Sun Pharma, 20 mg, bottle, 100 count, NDC 57664-0339-88 - discontinued
    • Amphetamine mixed salts extended release capsule, Sun Pharma, 25 mg, bottle, 100 count, NDC 57664-0340-88 - discontinued
    • Amphetamine mixed salts extended release capsule, Sun Pharma, 30 mg, bottle, 100 count, NDC 57664-0341-88 - discontinued
    • Amphetamine mixed salts extended release capsule, Sun Pharma, 5 mg, bottle, 100 count, NDC 57664-0336-88 - discontinued
    • Amphetamine mixed salts extended release capsule, Teva, 15 mg, bottle, 100 count, NDC 00228-3063-11
    • Amphetamine mixed salts extended release capsule, Teva, 20 mg, bottle, 100 count, NDC 00228-3060-11
    • Amphetamine mixed salts extended release capsule, Teva, 30 mg, bottle, 100 count, NDC 00228-3061-11

Reason for the Shortage

    • Amneal did not provide a reason for the shortage.
    • Aytu BioPharma has Adzenys XR oral disintegrating tablets available.
    • Camber discontinued amphetamine mixed salts extended-release capsules.
    • Lannett did not provide a reason for the shortage. Lannett updated the NDC numbers recently.
    • Mallincrodt refuses to provide availability information.
    • Par has discontinued amphetamines mixed salts extended-release capsules.
    • Prasco has discontinued amphetamine mixed salts extended-release capsules authorized generic because Shire is no longer supplying the company with product. Inventory is being distributed until remaining supply is depleted.
    • Rhodes did not provide a reason for the shortage.
    • Sandoz has discontinued amphetamine mixed salts extended-release capsules.
    • Sun Pharma has discontinued amphetamines mixed salts extended-release capsules.
    • Shire has Adderall XR and Mydayis extended-release capsules available.
    • Teva did not provide a reason for the shortage.
    • Tris Pharma has Dynavel XR tablets and suspension available.

Available Products

    • Adderall XR extended release capsule, Shire, 10 mg, bottle, 100 count, NDC 54092-0383-01
    • Adderall XR extended release capsule, Shire, 15 mg, bottle, 100 count, NDC 54092-0385-01
    • Adderall XR extended release capsule, Shire, 20 mg, bottle, 100 count, NDC 54092-0387-01
    • Adderall XR extended release capsule, Shire, 25 mg, bottle, 100 count, NDC 54092-0389-01
    • Adderall XR extended release capsule, Shire, 30 mg, bottle, 100 count, NDC 54092-0391-01
    • Adderall XR extended release capsule, Shire, 5 mg, bottle, 100 count, NDC 54092-0381-01
    • Adzenys XR ODT oral disintegrating tablet, Aytu BioPharma, extended release 12.5 mg, unit-dose blister pack, 30 count, NDC 70165-0020-30
    • Adzenys XR ODT oral disintegrating tablet, Aytu BioPharma, extended release 15.7 mg, unit-dose blister pack, 30 count, NDC 70165-0025-30
    • Adzenys XR ODT oral disintegrating tablet, Aytu BioPharma, extended release 18.8 mg, unit-dose blister pack, 30 count, NDC 70165-0030-30
    • Adzenys XR ODT oral disintegrating tablet, Aytu BioPharma, extended release 3.1 mg, unit-dose blister pack, 30 count, NDC 70165-0005-30
    • Adzenys XR ODT oral disintegrating tablet, Aytu BioPharma, extended release 6.3 mg, unit-dose blister pack, 30 count, NDC 70165-0010-30
    • Adzenys XR ODT oral disintegrating tablet, Aytu BioPharma, extended release 9.4 mg, unit-dose blister pack, 30 count, NDC 70165-0015-30
    • Dynavel XR oral extended release tablet, Tris Pharma, 10 mg, bottle, 30 count, NDC 24478-0108-01
    • Dynavel XR oral extended release tablet, Tris Pharma, 15 mg, bottle, 30 count, NDC 24478-0109-01
    • Dynavel XR oral extended release tablet, Tris Pharma, 20 mg, bottle, 30 count, NDC 24478-0110-01
    • Dynavel XR oral extended release tablet, Tris Pharma, 5 mg, bottle, 30 count, NDC 24478-0106-01
    • Dynavel XR oral suspension, Tris Pharma, 2.5 mg/mL, 464 mL bottle, NDC 24478-0102-01
    • Mydayis oral extended release capsule, Shire, 12.5 mg, bottle, 100 count, NDC 54092-0468-01
    • Mydayis oral extended release capsule, Shire, 25 mg, bottle, 100 count, NDC 54092-0471-01
    • Mydayis oral extended release capsule, Shire, 37.5 mg, bottle, 100 count, NDC 54092-0474-01
    • Mydayis oral extended release capsule, Shire, 50 mg, bottle, 100 count, NDC 54092-0477-01
    • Amphetamine mixed salts extended release capsule, Teva, 10 mg, bottle, 100 count, NDC 00228-3059-11
    • Amphetamine mixed salts extended release capsule, Teva, 25 mg, bottle, 100 count, NDC 00228-3064-11
    • Amphetamine mixed salts extended release capsule, Teva, 5 mg, bottle, 100 count, NDC 00228-3062-11

Estimated Resupply Dates

    • Amneal has amphetamine 5 mg, 10 mg, and 30 mg extended-release capsules on allocation. The 15 mg, 20 mg, and 25 mg extended-release capsules are on back order and the company cannot estimate a release date.
    • Lannett has all amphetamine extended-release capsules on allocation.
    • Rhodes has amphetamine extended-release capsules on back order and the company cannot estimate a release date.
    • Teva has amphetamine 15 mg, 20 mg, and 30 mg extended-release capsules on intermittent back order and the company is releasing supplies as they become available.

Safety

    • The CDC has issued a health advisory regarding potential disrupted access to care in patients taking prescription stimulant medications and possible increased risks for injury and overdose. The health advisory can be found at https://emergency.cdc.gov/han/2024/han00510.asp

Alternative Agents & Management

    • Aytu BioPharma's Adzenys XR ODT is bioequivalent to Adderall XR. https://www.biospace.com/article/releases/aytu-biopharma-inc-continues-availability-of-adzenys-xr-odt-r-as-the-only-fda-approved-orally-disintegrating-tablet-odt-medication-that-is-bioequivalent-to-adderall-xr-r-for-adhd-patients/#:~:text=Adzenys%20XR-ODT%20is%20available%20by%20prescription%20only%2C%20is%20bioequivalent,patients%20six%20years%20and%20older

Updated

Updated July 1, 2024 by Leslie Jensen, PharmD, Drug Information Specialist. Created August 24, 2022 by Leslie Jensen, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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