adderall

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

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adderall
Generic Name dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amphetamine aspartate monohydrate 3.125 mg/1, amphetamine sulfate 3.125 mg/1, dextroamphetamine saccharate 3.125 mg/1, dextroamphetamine sulfate 3.125 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 57844-112
Product ID 57844-112_79af1dc6-c7cf-41b1-a750-e9b47c2187ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040422
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2014-06-18

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 57844112
Hyphenated Format 57844-112

Supplemental Identifiers

RxCUI
541363 541365 541878 541879 541892 541894 577957 577960 577961 577962 687043 687045 1009145 1009147
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 (source: ndc)
Generic Name dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate (source: ndc)
Application Number ANDA040422 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.125 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (57844-112-01)
source: ndc

Packages (1)

57844-112-01 100 TABLET in 1 BOTTLE (57844-112-01)

Ingredients (4)

amphetamine aspartate monohydrate (3.125 mg/1) amphetamine sulfate (3.125 mg/1) dextroamphetamine saccharate (3.125 mg/1) dextroamphetamine sulfate (3.125 mg/1)

Linked Drug Pages (1)

Adderall ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "79af1dc6-c7cf-41b1-a750-e9b47c2187ff", "openfda": {"unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["541363", "541365", "541878", "541879", "541892", "541894", "577957", "577960", "577961", "577962", "687043", "687045", "1009145", "1009147"], "spl_set_id": ["f22635fe-821d-4cde-aa12-419f8b53db81"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (57844-112-01)", "package_ndc": "57844-112-01", "marketing_start_date": "20140618"}], "brand_name": "Adderall", "product_id": "57844-112_79af1dc6-c7cf-41b1-a750-e9b47c2187ff", "dosage_form": "TABLET", "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": "57844-112", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Adderall", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE MONOHYDRATE", "strength": "3.125 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "3.125 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "3.125 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "3.125 mg/1"}], "application_number": "ANDA040422", "marketing_category": "ANDA", "marketing_start_date": "20140618", "listing_expiration_date": "20261231"}