dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (0527-0793)

Drug Facts

Product Profile

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

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

Labeler lannett company, inc.

Dosage Form CAPSULE, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

amphetamine aspartate monohydrate 5 mg/1, amphetamine sulfate 5 mg/1, dextroamphetamine saccharate 5 mg/1, dextroamphetamine sulfate 5 mg/1

Manufacturer

Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-0793

Product ID 0527-0793_956b750f-3c89-4a24-9cf5-f65d04ed5c34

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214403

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2021-11-26

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 05270793

Hyphenated Format 0527-0793

Supplemental Identifiers

RxCUI

861221 861223 861225 861227 861232 861237

UPC

0305270791376 0305870193310 0305270790379 0305270794377

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

Application Number ANDA214403 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1

source: ndc

Packaging

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-0793-37)

source: ndc

Packages (1)

0527-0793-37 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-0793-37)

Ingredients (4)

amphetamine aspartate monohydrate (5 mg/1) amphetamine sulfate (5 mg/1) dextroamphetamine saccharate (5 mg/1) dextroamphetamine sulfate (5 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": "956b750f-3c89-4a24-9cf5-f65d04ed5c34", "openfda": {"upc": ["0305270791376", "0305870193310", "0305270790379", "0305270794377"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["861221", "861223", "861225", "861227", "861232", "861237"], "spl_set_id": ["e95bdaf9-007a-4088-b969-fee38a97a475"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-0793-37)", "package_ndc": "0527-0793-37", "marketing_start_date": "20211126"}], "brand_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate", "product_id": "0527-0793_956b750f-3c89-4a24-9cf5-f65d04ed5c34", "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": "0527-0793", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate", "labeler_name": "Lannett Company, Inc.", "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": "5 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "5 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "5 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "5 mg/1"}], "application_number": "ANDA214403", "marketing_category": "ANDA", "marketing_start_date": "20211126", "listing_expiration_date": "20261231"}