dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate (63629-2378)

Drug Facts

Product Profile

Brand Name dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

Generic Name dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

Labeler bryant ranch prepack

Dosage Form TABLET

Routes

ORAL

Active Ingredients

amphetamine aspartate monohydrate 3.75 mg/1, amphetamine sulfate 3.75 mg/1, dextroamphetamine saccharate 3.75 mg/1, dextroamphetamine sulfate 3.75 mg/1

Manufacturer

Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-2378

Product ID 63629-2378_95118bcb-4e93-4255-8005-d4baf807364c

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209799

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2018-07-04

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 636292378

Hyphenated Format 63629-2378

Supplemental Identifiers

RxCUI

577957

UNII

O1ZPV620O4 6DPV8NK46S G83415V073 JJ768O327N

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, dextroamphetamine sulfate and amphetamine sulfate (source: ndc)

Generic Name dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate (source: ndc)

Application Number ANDA209799 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

3.75 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (63629-2378-1)

source: ndc

Packages (1)

63629-2378-1 100 TABLET in 1 BOTTLE (63629-2378-1)

Ingredients (4)

amphetamine aspartate monohydrate (3.75 mg/1) amphetamine sulfate (3.75 mg/1) dextroamphetamine saccharate (3.75 mg/1) dextroamphetamine sulfate (3.75 mg/1)

Linked Drug Pages (1)

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "95118bcb-4e93-4255-8005-d4baf807364c", "openfda": {"unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["577957"], "spl_set_id": ["dff226eb-0ec4-498a-b660-a67e57ea2030"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (63629-2378-1)", "package_ndc": "63629-2378-1", "marketing_start_date": "20210224"}], "brand_name": "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE", "product_id": "63629-2378_95118bcb-4e93-4255-8005-d4baf807364c", "dosage_form": "TABLET", "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": "63629-2378", "dea_schedule": "CII", "generic_name": "dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE", "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": "ANDA209799", "marketing_category": "ANDA", "marketing_start_date": "20180704", "listing_expiration_date": "20261231"}