Drug shortages

Lisdexamfetamine Dimesylate Capsule

Hikma Pharmaceuticals USA, Inc. · Limited Availability · Reason: Shortage of an active ingredient

Current0054-0373-25Psychiatry
Open FDA's page for this record
Update type
Reverified
Initial posting date
07/14/2023
Package NDC
0054-0373-25
Generic name
Lisdexamfetamine Dimesylate Capsule
Contact info
800-631-2174
Availability
Limited Availability
Related info
Available on allocation
Update date
09/18/2026
Dosage form
Capsule
Presentation
Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 0054-0373-25)
Company name
Hikma Pharmaceuticals USA, Inc.
Shortage reason
Shortage of an active ingredient
Status
Current
Therapeutic category
Psychiatry
Harmonized identifiers (openFDA)
Application number
ANDA202827
Brand name
LISDEXAMFETAMINE DIMESYLATE
Generic name
LISDEXAMFETAMINE DIMESYLATE
Manufacturer name
Hikma Pharmaceuticals USA Inc.
Product NDC
0054-0373, 0054-0660, 0054-0370, 0054-0371, 0054-0372, 0054-0374, 0054-0375
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
LISDEXAMFETAMINE DIMESYLATE
RxCUI
854830, 854834, 854838, 854842, 854846, 854850, 1593856
SPL ID
ccd9e87c-bd03-4fe0-8129-41c1ced49c8d
SPL set ID
6740a621-9bec-4178-a4fc-a3fc89f34e0a
Package NDC
0054-0660-25, 0054-0370-25, 0054-0371-25, 0054-0372-25, 0054-0373-25, 0054-0374-25, 0054-0375-25
UNII
SJT761GEGS
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.