dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate (42806-344)

Drug Facts

Product Profile

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

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

Labeler epic pharma, llc

Dosage Form TABLET

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

Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-344

Product ID 42806-344_f11301e2-3b5d-468d-b44c-45839e7e5dfb

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040444

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2019-03-15

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 42806344

Hyphenated Format 42806-344

Supplemental Identifiers

RxCUI

541363 541878 541892 577957 577961

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, dextroamphetamine sulfate and amphetamine sulfate (source: ndc)

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

Application Number ANDA040444 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE, PLASTIC (42806-344-01)

source: ndc

Packages (1)

42806-344-01 100 TABLET in 1 BOTTLE, PLASTIC (42806-344-01)

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, Dextroamphetamine Sulfate and Amphetamine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "f11301e2-3b5d-468d-b44c-45839e7e5dfb", "openfda": {"unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["541363", "541878", "541892", "577957", "577961"], "spl_set_id": ["1757e132-061d-4773-89ed-fdc77f69008f"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (42806-344-01)", "package_ndc": "42806-344-01", "marketing_start_date": "20190315"}], "brand_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate", "product_id": "42806-344_f11301e2-3b5d-468d-b44c-45839e7e5dfb", "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": "42806-344", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine Saccharate, Amphetamine Aspartate, 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": "ANDA040444", "marketing_category": "ANDA", "marketing_start_date": "20190315", "listing_expiration_date": "20261231"}