Package 0406-8953-01
Brand: mixed salts of a single entity amphetamine product xr
Generic: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfatePackage 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
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"}