dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate

Generic: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amphetamine aspartate monohydrate 3.125 mg/1, amphetamine sulfate 3.125 mg/1, dextroamphetamine saccharate 3.125 mg/1, dextroamphetamine sulfate 3.125 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-9488
Product ID 63629-9488_9b7b4e85-37f6-4db8-a2bf-e466322ee10c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213111
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2021-09-09

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 636299488
Hyphenated Format 63629-9488

Supplemental Identifiers

RxCUI
687043
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 monohydrate, dextroamphetamine sulfate, and amphetamine sulfate (source: ndc)
Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate (source: ndc)
Application Number ANDA213111 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.125 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (63629-9488-1)
source: ndc

Packages (1)

63629-9488-1 100 TABLET in 1 BOTTLE (63629-9488-1)

Ingredients (4)

amphetamine aspartate monohydrate (3.125 mg/1) amphetamine sulfate (3.125 mg/1) dextroamphetamine saccharate (3.125 mg/1) dextroamphetamine sulfate (3.125 mg/1)

Linked Drug Pages (1)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9b7b4e85-37f6-4db8-a2bf-e466322ee10c", "openfda": {"unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["687043"], "spl_set_id": ["3533afbe-6926-4ca4-a6d4-7579499006af"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (63629-9488-1)", "package_ndc": "63629-9488-1", "marketing_start_date": "20221213"}], "brand_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate", "product_id": "63629-9488_9b7b4e85-37f6-4db8-a2bf-e466322ee10c", "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": "63629-9488", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate", "labeler_name": "Bryant Ranch Prepack", "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": "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": "ANDA213111", "marketing_category": "ANDA", "marketing_start_date": "20210909", "listing_expiration_date": "20261231"}