NDC 0406-8954

Mixed Salts of a Single Entity Amphetamine Product XR

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

Mixed Salts of a Single Entity Amphetamine Product XR is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Specgx Llc. The primary component is Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate.

Product ID0406-8954_0e19de4d-0f73-4788-b980-73d2dc76ac1f
NDC0406-8954
Product TypeHuman Prescription Drug
Proprietary NameMixed Salts of a Single Entity Amphetamine Product XR
Generic NameDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-04-22
Marketing CategoryANDA / ANDA
Application NumberANDA211547
Labeler NameSpecGx LLC
Substance NameAMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active Ingredient Strength5 mg/1; mg/1; mg/1; mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0406-8954-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8954-01)
Marketing Start Date2019-04-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0406-8954-01 [00406895401]

Mixed Salts of a Single Entity Amphetamine Product XR CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211547
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-22

Drug Details

Active Ingredients

IngredientStrength
DEXTROAMPHETAMINE SULFATE5 mg/1

Pharmacological Class

  • Central Nervous System Stimulant [EPC]
  • Central Nervous System Stimulation [PE]

NDC Crossover Matching brand name "Mixed Salts of a Single Entity Amphetamine Product XR" or generic name "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate"

NDCBrand NameGeneric Name
0228-3059Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
0228-3060Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
0228-3061Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
0228-3062Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
0228-3063Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
0228-3064Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
57664-336Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-ReleaseDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate
0406-8951Mixed Salts of a Single Entity Amphetamine ProductDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate
0406-8952Mixed Salts of a Single Entity Amphetamine ProductDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate
0406-8953Mixed Salts of a Single Entity Amphetamine ProductDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate
0406-8954Mixed Salts of a Single Entity Amphetamine ProductDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate
0406-8955Mixed Salts of a Single Entity Amphetamine ProductDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate
0406-8956Mixed Salts of a Single Entity Amphetamine ProductDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.