NDC 54092-391

Adderall XR

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate

Adderall XR is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Dextroamphetamine Sulfate; Dextroamphetamine Saccharate; Amphetamine Aspartate Monohydrate; Amphetamine Sulfate.

• Product ID: 54092-391_05c01190-093d-41b3-8fe6-4ad8d6e2aee3
• NDC: 54092-391
• Product Type: Human Prescription Drug
• Proprietary Name: Adderall XR
• Generic Name: Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2001-10-11
• Marketing Category: NDA / NDA
• Application Number: NDA021303
• Labeler Name: Takeda Pharmaceuticals America, Inc.
• Substance Name: DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE
• Active Ingredient Strength: 8 mg/1; mg/1; mg/1; mg/1
• Pharm Classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 54092-391-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-391-01)

• Marketing Start Date: 2002-05-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54092-391-01 [54092039101]

Adderall XR CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021303
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-05-22

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROAMPHETAMINE SULFATE	7.5 mg/1

OpenFDA Data

• SPL SET ID: aff45863-ffe1-4d4f-8acf-c7081512a6c0
• Manufacturer:
  • Shire US Manufacturing Inc.
• UNII:
  • 6DPV8NK46S
  • G83415V073
  • O1ZPV620O4
  • JJ768O327N
• RxNorm Concept Unique ID - RxCUI:
  • 861238
  • 861232
  • 861233
  • 861237
  • 861227
  • 861226
  • 861225
  • 861224
  • 861223
  • 861222
  • 861221
  • 861228
• UPC Code:
  • 0354092383016
  • 0354092385010
  • 0354092387014
  • 0354092391011
  • 0354092381012
  • 0354092389018

Pharmacological Class

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

Medicade Reported Pricing

54092039101 ADDERALL XR 30 MG CAPSULE

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Adderall XR" or generic name "Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate"

NDC	Brand Name	Generic Name
54092-391	Adderall XR	Adderall XR
54092-381	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
54092-383	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
54092-385	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
54092-387	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
54092-389	Adderall	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
0527-0790	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
0527-0791	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
0527-0792	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
0527-0793	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
0527-0794	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
0527-0795	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate