dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (0115-1489)

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 amneal pharmaceuticals of new york llc

Dosage Form CAPSULE

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

Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1489

Product ID 0115-1489_ac31e7dc-211c-498a-b54d-c62da851e3ec

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA076852

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2016-02-16

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 01151489

Hyphenated Format 0115-1489

Supplemental Identifiers

RxCUI

861221 861223 861225 861227 861232 861237

UPC

0301151491014 0301151489011 0301151490017 0301151488014 0301151487017

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 ANDA076852 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1

source: ndc

Packaging

100 CAPSULE in 1 BOTTLE (0115-1489-01)

source: ndc

Packages (1)

0115-1489-01 100 CAPSULE in 1 BOTTLE (0115-1489-01)

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

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "ac31e7dc-211c-498a-b54d-c62da851e3ec", "openfda": {"upc": ["0301151491014", "0301151489011", "0301151490017", "0301151488014", "0301151487017"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["861221", "861223", "861225", "861227", "861232", "861237"], "spl_set_id": ["89c4b21a-1a65-41ef-8718-1619c2ba8591"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0115-1489-01)", "package_ndc": "0115-1489-01", "marketing_start_date": "20160216"}], "brand_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate", "product_id": "0115-1489_ac31e7dc-211c-498a-b54d-c62da851e3ec", "dosage_form": "CAPSULE", "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": "0115-1489", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate", "labeler_name": "Amneal Pharmaceuticals of New York 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": "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": "ANDA076852", "marketing_category": "ANDA", "marketing_start_date": "20160216", "listing_expiration_date": "20261231"}