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10/18/2023

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, 25 mg, bottle, 100 count, NDC 00527-5514-37
    • 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, Rhodes, 10 mg, bottle, 100 count, NDC 42858-0610-10
    • Amphetamine mixed salts extended release capsule, Rhodes, 25 mg, bottle, 100 count, NDC 42858-0325-01
    • 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
    • Amphetamine mixed salts extended release capsule, Sandoz, 15 mg, bottle, 100 count, NDC 00781-2343-01
    • Amphetamine mixed salts extended release capsule, Sandoz, 20 mg, bottle, 100 count, NDC 00781-2352-01
    • Amphetamine mixed salts extended release capsule, Sandoz, 25 mg, bottle, 100 count, NDC 00781-2368-01
    • Amphetamine mixed salts extended release capsule, Sandoz, 30 mg, bottle, 100 count, NDC 00781-2371-01
    • Amphetamine mixed salts extended release capsule, Sandoz, 5 mg, bottle, 100 count, NDC 00781-2329-01
    • 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, 10 mg, bottle, 100 count, NDC 00228-3059-11
    • 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, 25 mg, bottle, 100 count, NDC 00228-3064-11
    • Amphetamine mixed salts extended release capsule, Teva, 30 mg, bottle, 100 count, NDC 00228-3061-11
    • Amphetamine mixed salts extended release capsule, Teva, 5 mg, bottle, 100 count, NDC 00228-3062-11

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.
    • Mallincrodt refuses to provide availability information.
    • Par has discontinued amphetamines mixed salts extended-release capsules.
    • Prasco has amphetamine mixed salts extended-release capsules available for contracted customers.
    • Rhodes did not provide a reason for the shortage.
    • Sandoz is prioritizing amphetamine mixed salts extended-release capsules to current customers.
    • 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, Lannett, 10 mg, bottle, 100 count, NDC 00527-5511-37
    • Amphetamine mixed salts extended release capsule, Lannett, 15 mg, bottle, 100 count, NDC 00527-5512-37
    • Amphetamine mixed salts extended release capsule, Lannett, 20 mg, bottle, 100 count, NDC 00527-5513-37
    • Amphetamine mixed salts extended release capsule, Lannett, 30 mg, bottle, 100 count, NDC 00527-5515-37
    • Amphetamine mixed salts extended release capsule, Lannett, 5 mg, bottle, 100 count, NDC 00527-5510-37
    • Amphetamine mixed salts extended release capsule, Prasco, 10 mg, bottle, 100 count, NDC 66993-0595-02
    • Amphetamine mixed salts extended release capsule, Prasco, 15 mg, bottle, 100 count, NDC 66993-0596-02
    • Amphetamine mixed salts extended release capsule, Prasco, 20 mg, bottle, 100 count, NDC 66993-0597-02
    • Amphetamine mixed salts extended release capsule, Prasco, 25 mg, bottle, 100 count, NDC 66993-0598-02
    • Amphetamine mixed salts extended release capsule, Prasco, 30 mg, bottle, 100 count, NDC 66993-0599-02
    • Amphetamine mixed salts extended release capsule, Prasco, 5 mg, bottle, 100 count, NDC 66993-0594-02
    • 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, 30 mg, bottle, 100 count, NDC 42858-0930-01

Estimated Resupply Dates

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

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 October 18, 2023 by Leslie Jensen, PharmD, Drug Information Specialist. Created August 24, 2022 by Leslie Jensen, PharmD, Drug Information Specialist. © 2023, Drug Information Service, University of Utah, Salt Lake City, UT.

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