dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

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

Labeler: elite laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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 elite laboratories, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amphetamine aspartate monohydrate 1.25 mg/1, amphetamine sulfate 1.25 mg/1, dextroamphetamine saccharate 1.25 mg/1, dextroamphetamine sulfate 1.25 mg/1

Manufacturer
Elite Laboratories, Inc.

Identifiers & Regulatory

Product NDC 64850-500
Product ID 64850-500_b65e0266-7172-4730-8f93-eb42e08fb7b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211352
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2022-12-29

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 64850500
Hyphenated Format 64850-500

Supplemental Identifiers

RxCUI
541363 541878 541892 577957 577961 687043 1009145
UPC
0364850502016 0364850506014 0364850501019 0364850504010 0364850500012 0364850505017 0364850503013
UNII
O1ZPV620O4 6DPV8NK46S G83415V073 JJ768O327N

Packaging Origin

Original Packager
true

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 ANDA211352 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (64850-500-01)
  • 500 TABLET in 1 BOTTLE (64850-500-05)
  • 30 TABLET in 1 BOTTLE (64850-500-30)
source: ndc

Packages (3)

64850-500-01 100 TABLET in 1 BOTTLE (64850-500-01) 64850-500-05 500 TABLET in 1 BOTTLE (64850-500-05) 64850-500-30 30 TABLET in 1 BOTTLE (64850-500-30)

Ingredients (4)

amphetamine aspartate monohydrate (1.25 mg/1) amphetamine sulfate (1.25 mg/1) dextroamphetamine saccharate (1.25 mg/1) dextroamphetamine sulfate (1.25 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": "b65e0266-7172-4730-8f93-eb42e08fb7b8", "openfda": {"upc": ["0364850502016", "0364850506014", "0364850501019", "0364850504010", "0364850500012", "0364850505017", "0364850503013"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["541363", "541878", "541892", "577957", "577961", "687043", "1009145"], "spl_set_id": ["e677690f-790f-4626-ad78-097cdb6ea540"], "manufacturer_name": ["Elite Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (64850-500-01)", "package_ndc": "64850-500-01", "marketing_start_date": "20221229"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (64850-500-05)", "package_ndc": "64850-500-05", "marketing_start_date": "20221229"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (64850-500-30)", "package_ndc": "64850-500-30", "marketing_start_date": "20221229"}], "brand_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate", "product_id": "64850-500_b65e0266-7172-4730-8f93-eb42e08fb7b8", "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": "64850-500", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate", "labeler_name": "Elite Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE MONOHYDRATE", "strength": "1.25 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "1.25 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "1.25 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "1.25 mg/1"}], "application_number": "ANDA211352", "marketing_category": "ANDA", "marketing_start_date": "20221229", "listing_expiration_date": "20261231"}