Package 0480-3685-01
Brand: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
Generic: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfatePackage Facts
Identity
Package NDC
0480-3685-01
Digits Only
0480368501
Product NDC
0480-3685
Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3685-01)
Marketing
Marketing Status
Brand
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
Generic
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "df4fa83e-494c-4091-8d34-9328fd030ccd", "openfda": {"unii": ["JJ768O327N", "O1ZPV620O4", "G83415V073", "6DPV8NK46S"], "rxcui": ["1927610", "1927617", "1927630", "1927637"], "spl_set_id": ["5e84ef60-3050-40d9-9f14-66b85d289e17"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3685-01)", "package_ndc": "0480-3685-01", "marketing_start_date": "20231010"}], "brand_name": "dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate", "product_id": "0480-3685_df4fa83e-494c-4091-8d34-9328fd030ccd", "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": "0480-3685", "dea_schedule": "CII", "generic_name": "dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate", "labeler_name": "Teva Pharmaceuticals, Inc.", "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": "9.375 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "9.375 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "9.375 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "9.375 mg/1"}], "application_number": "ANDA210876", "marketing_category": "ANDA", "marketing_start_date": "20231010", "listing_expiration_date": "20261231"}