adderall xr

Generic: dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name adderall xr
Generic Name dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate
Labeler takeda pharmaceuticals america, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

amphetamine aspartate monohydrate 6.25 mg/1, amphetamine sulfate 6.25 mg/1, dextroamphetamine saccharate 6.25 mg/1, dextroamphetamine sulfate 6.25 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 54092-389
Product ID 54092-389_36ca0eef-16f8-46d7-b92b-1aac1f78d70c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021303
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2002-05-22

Pharmacologic Class

Classes
central nervous system stimulant [epc] central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54092389
Hyphenated Format 54092-389

Supplemental Identifiers

RxCUI
861221 861222 861223 861224 861225 861226 861227 861228 861232 861233 861237 861238
UPC
0354092387014 0354092391011
UNII
O1ZPV620O4 6DPV8NK46S G83415V073 JJ768O327N

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name adderall xr (source: ndc)
Generic Name dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate (source: ndc)
Application Number NDA021303 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-389-01)
source: ndc

Packages (1)

54092-389-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-389-01)

Ingredients (4)

amphetamine aspartate monohydrate (6.25 mg/1) amphetamine sulfate (6.25 mg/1) dextroamphetamine saccharate (6.25 mg/1) dextroamphetamine sulfate (6.25 mg/1)

Linked Drug Pages (1)

Adderall XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "36ca0eef-16f8-46d7-b92b-1aac1f78d70c", "openfda": {"upc": ["0354092387014", "0354092391011"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["861221", "861222", "861223", "861224", "861225", "861226", "861227", "861228", "861232", "861233", "861237", "861238"], "spl_set_id": ["aff45863-ffe1-4d4f-8acf-c7081512a6c0"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-389-01)", "package_ndc": "54092-389-01", "marketing_start_date": "20020522"}], "brand_name": "Adderall XR", "product_id": "54092-389_36ca0eef-16f8-46d7-b92b-1aac1f78d70c", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central 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]"], "product_ndc": "54092-389", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Adderall", "brand_name_suffix": "XR", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE MONOHYDRATE", "strength": "6.25 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "6.25 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "6.25 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "6.25 mg/1"}], "application_number": "NDA021303", "marketing_category": "NDA", "marketing_start_date": "20020522", "listing_expiration_date": "20261231"}