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Drug shortages

Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet

Granules Pharmaceuticals Inc. · Unavailable · Reason: Shortage of an active ingredient

Current70010-113-01Psychiatry
Open FDA's page for this record
Update type
Reverified
Initial posting date
10/12/2022
Package NDC
70010-113-01
Generic name
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet
Contact info
877-770-3183
Availability
Unavailable
Related info
Estimated recovery: October 2026
Update date
10/13/2026
Dosage form
Tablet
Company name
Granules Pharmaceuticals Inc.
Shortage reason
Shortage of an active ingredient
Status
Current
Presentation

Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 70010-113-01)

Therapeutic category
Psychiatry
Harmonized identifiers (openFDA)
Application number
ANDA215771
Brand name
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Generic name
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Manufacturer name
Granules Pharmaceuticals Inc.
Product NDC
70010-113, 70010-111, 70010-112, 70010-114, 70010-115, 70010-116, 70010-117
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE
RxCUI
541363, 541878, 541892, 577957, 577961, 687043, 1009145
SPL ID
56c7c921-e560-c5ad-e063-6294a90a4c81
SPL set ID
b0b4eccc-34c7-483d-966f-82d588358e1b
Package NDC
70010-111-01, 70010-111-03, 70010-112-01, 70010-112-03, 70010-113-01, 70010-113-03, 70010-114-01, 70010-114-03, 70010-115-01, 70010-115-03, 70010-116-01, 70010-116-03, 70010-117-01, 70010-117-03
UNII
6DPV8NK46S, JJ768O327N, O1ZPV620O4, G83415V073
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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.