Package 0406-8953-01

Brand: mixed salts of a single entity amphetamine product xr

Generic: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
NDC Package

Package Facts

Identity

Package NDC 0406-8953-01
Digits Only 0406895301
Product NDC 0406-8953
Description

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8953-01)

Marketing

Marketing Status
Marketed Since 2019-04-22
Brand mixed salts of a single entity amphetamine product xr
Generic dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "d35f2f82-b0de-4f2a-a740-3d95c364cd7b", "openfda": {"upc": ["0304068956010", "0304068955013"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["861221", "861223", "861225", "861227", "861232", "861237"], "spl_set_id": ["60a2834c-38a2-480e-b89c-563e9cf0c9c3"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8953-01)", "package_ndc": "0406-8953-01", "marketing_start_date": "20190422"}], "brand_name": "Mixed Salts of a Single Entity Amphetamine Product XR", "product_id": "0406-8953_d35f2f82-b0de-4f2a-a740-3d95c364cd7b", "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": "0406-8953", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mixed Salts of a Single Entity Amphetamine Product", "brand_name_suffix": "XR", "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": "ANDA211547", "marketing_category": "ANDA", "marketing_start_date": "20190422", "listing_expiration_date": "20261231"}