dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfate

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

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfate
Generic Name dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfate
Labeler specgx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amphetamine aspartate monohydrate 5 mg/1, amphetamine sulfate 5 mg/1, dextroamphetamine saccharate 5 mg/1, dextroamphetamine sulfate 5 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-8893
Product ID 0406-8893_0d3fb5ba-ff79-4862-bc1d-45b8343e115b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040440
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2003-10-07

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 04068893
Hyphenated Format 0406-8893

Supplemental Identifiers

RxCUI
541363 541878 541892 577957 577961 1009145
UPC
0304068885013 0304068892011 0304068893018 0304068891014 0304068884016 0304068894015
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 and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfate (source: ndc)
Generic Name dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfate (source: ndc)
Application Number ANDA040440 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0406-8893-01)
source: ndc

Packages (1)

0406-8893-01 100 TABLET in 1 BOTTLE (0406-8893-01)

Ingredients (4)

amphetamine aspartate monohydrate (5 mg/1) amphetamine sulfate (5 mg/1) dextroamphetamine saccharate (5 mg/1) dextroamphetamine sulfate (5 mg/1)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0d3fb5ba-ff79-4862-bc1d-45b8343e115b", "openfda": {"upc": ["0304068885013", "0304068892011", "0304068893018", "0304068891014", "0304068884016", "0304068894015"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["541363", "541878", "541892", "577957", "577961", "1009145"], "spl_set_id": ["72ddd1c9-ddbd-4c95-acd9-003189a353a3"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0406-8893-01)", "package_ndc": "0406-8893-01", "marketing_start_date": "20031007"}], "brand_name": "Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate", "product_id": "0406-8893_0d3fb5ba-ff79-4862-bc1d-45b8343e115b", "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": "0406-8893", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE MONOHYDRATE", "strength": "5 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "5 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "5 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "5 mg/1"}], "application_number": "ANDA040440", "marketing_category": "ANDA", "marketing_start_date": "20031007", "listing_expiration_date": "20261231"}