dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release (42858-610)

Drug Facts

Product Profile

Brand Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release

Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate

Labeler rhodes pharmaceuticals l.p.

Dosage Form CAPSULE, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

amphetamine aspartate monohydrate 2.5 mg/1, amphetamine sulfate 2.5 mg/1, dextroamphetamine saccharate 2.5 mg/1, dextroamphetamine sulfate 2.5 mg/1

Manufacturer

Rhodes Pharmaceuticals L.P.

Identifiers & Regulatory

Product NDC 42858-610

Product ID 42858-610_2780ab8b-8fbf-4902-afc0-d9fd13a01cfb

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA210651

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2019-08-22

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 42858610

Hyphenated Format 42858-610

Supplemental Identifiers

RxCUI

861221 861223 861225 861227 861232 861237

UPC

0342858930017 0342858325011

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, and amphetamine sulfate extended-release (source: ndc)

Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate (source: ndc)

Application Number ANDA210651 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

2.5 mg/1

source: ndc

Packaging

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-610-01)

source: ndc

Packages (1)

42858-610-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-610-01)

Ingredients (4)

amphetamine aspartate monohydrate (2.5 mg/1) amphetamine sulfate (2.5 mg/1) dextroamphetamine saccharate (2.5 mg/1) dextroamphetamine sulfate (2.5 mg/1)

Linked Drug Pages (1)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2780ab8b-8fbf-4902-afc0-d9fd13a01cfb", "openfda": {"upc": ["0342858930017", "0342858325011"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["861221", "861223", "861225", "861227", "861232", "861237"], "spl_set_id": ["690e1ef4-caf7-4c48-a4ae-d2a0ab684e82"], "manufacturer_name": ["Rhodes Pharmaceuticals L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-610-01)", "package_ndc": "42858-610-01", "marketing_start_date": "20190822"}], "brand_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release", "product_id": "42858-610_2780ab8b-8fbf-4902-afc0-d9fd13a01cfb", "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": "42858-610", "dea_schedule": "CII", "generic_name": "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE", "labeler_name": "Rhodes Pharmaceuticals L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE MONOHYDRATE", "strength": "2.5 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "2.5 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "2.5 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "2.5 mg/1"}], "application_number": "ANDA210651", "marketing_category": "ANDA", "marketing_start_date": "20190822", "listing_expiration_date": "20261231"}