dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate

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

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
Labeler actavis pharma, 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
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0228-3064
Product ID 0228-3064_75c254af-0db3-4c40-83ad-f308be628dde
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077302
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2012-06-22

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 02283064
Hyphenated Format 0228-3064

Supplemental Identifiers

RxCUI
861221 861223 861225 861227 861232 861237
UPC
0302283059110 0302283064114 0302283063117
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 dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate (source: ndc)
Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate (source: ndc)
Application Number ANDA077302 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3064-11)
source: ndc

Packages (1)

0228-3064-11 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3064-11)

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)

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "75c254af-0db3-4c40-83ad-f308be628dde", "openfda": {"upc": ["0302283059110", "0302283064114", "0302283063117"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["861221", "861223", "861225", "861227", "861232", "861237"], "spl_set_id": ["c5c2d060-452c-4f76-ad93-2e41fd8f06c2"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3064-11)", "package_ndc": "0228-3064-11", "marketing_start_date": "20120622"}], "brand_name": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate", "product_id": "0228-3064_75c254af-0db3-4c40-83ad-f308be628dde", "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": "0228-3064", "dea_schedule": "CII", "generic_name": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate", "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": "ANDA077302", "marketing_category": "ANDA", "marketing_start_date": "20120622", "listing_expiration_date": "20271231"}