Package 0406-0805-01

Brand: mixed salts of a single-entity amphetamine product

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

Package Facts

Identity

Package NDC 0406-0805-01
Digits Only 0406080501
Product NDC 0406-0805
Description

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0805-01)

Marketing

Marketing Status
Marketed Since 2023-11-01
Brand mixed salts of a single-entity amphetamine product
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": "03d41c88-9c50-4406-91ba-7a086cad0366", "openfda": {"upc": ["0304060804012", "0304060805019", "0304060807013", "0304060803015"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["1927610", "1927617", "1927630", "1927637"], "spl_set_id": ["e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0805-01)", "package_ndc": "0406-0805-01", "marketing_start_date": "20231101"}], "brand_name": "Mixed Salts of a Single-Entity Amphetamine Product", "product_id": "0406-0805_03d41c88-9c50-4406-91ba-7a086cad0366", "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": "0406-0805", "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", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE MONOHYDRATE", "strength": "3.125 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "3.125 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "3.125 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "3.125 mg/1"}], "application_number": "ANDA211546", "marketing_category": "ANDA", "marketing_start_date": "20231101", "listing_expiration_date": "20261231"}