dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate (35573-466)

Drug Facts

Product Profile

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

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

Labeler burel pharmaceuticals, llc

Dosage Form CAPSULE, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

amphetamine aspartate monohydrate 3.75 mg/1, amphetamine sulfate 3.75 mg/1, dextroamphetamine saccharate 3.75 mg/1, dextroamphetamine sulfate 3.75 mg/1

Manufacturer

Burel Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 35573-466

Product ID 35573-466_01fe666a-d04e-4dce-af71-8db45bbde653

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212037

DEA Schedule cii

Marketing Start 2019-12-16

Marketing End 2028-02-29

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 35573466

Hyphenated Format 35573-466

Supplemental Identifiers

RxCUI

861221 861223 861225 861227 861232 861237

UPC

0335573466022 0335573468026 0335573467029

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 (source: ndc)

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

Application Number ANDA212037 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

3.75 mg/1

source: ndc

Packaging

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-466-02)

source: ndc

Packages (1)

35573-466-02 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-466-02)

Ingredients (4)

amphetamine aspartate monohydrate (3.75 mg/1) amphetamine sulfate (3.75 mg/1) dextroamphetamine saccharate (3.75 mg/1) dextroamphetamine sulfate (3.75 mg/1)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "01fe666a-d04e-4dce-af71-8db45bbde653", "openfda": {"upc": ["0335573466022", "0335573468026", "0335573467029"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["861221", "861223", "861225", "861227", "861232", "861237"], "spl_set_id": ["bcdd2fe2-d0de-4a28-aced-40ac9ce5122d"], "manufacturer_name": ["Burel Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-466-02)", "package_ndc": "35573-466-02", "marketing_end_date": "20280229", "marketing_start_date": "20191216"}], "brand_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate", "product_id": "35573-466_01fe666a-d04e-4dce-af71-8db45bbde653", "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": "35573-466", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate", "labeler_name": "Burel Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE MONOHYDRATE", "strength": "3.75 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "3.75 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "3.75 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "3.75 mg/1"}], "application_number": "ANDA212037", "marketing_category": "ANDA", "marketing_end_date": "20280229", "marketing_start_date": "20191216"}