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

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

Labeler: sun pharmaceutical industries, 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 sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-641
Product ID 57664-641_177c0583-addd-49cc-e063-6394a90aa6cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040480
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2003-09-09

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 57664641
Hyphenated Format 57664-641

Supplemental Identifiers

RxCUI
541363 541878 541892 577957 577961 687043 1009145
UPC
0357664647080 0357664642085 0357664645086 0357664644089 0357664643082
UNII
6DPV8NK46S G83415V073 JJ768O327N H527KAP6L5

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 ANDA040480 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (57664-641-08)
source: ndc

Packages (1)

57664-641-08 100 TABLET in 1 BOTTLE, PLASTIC (57664-641-08)

Ingredients (4)

amphetamine aspartate (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": "177c0583-addd-49cc-e063-6394a90aa6cc", "openfda": {"upc": ["0357664647080", "0357664642085", "0357664645086", "0357664644089", "0357664643082"], "unii": ["6DPV8NK46S", "G83415V073", "JJ768O327N", "H527KAP6L5"], "rxcui": ["541363", "541878", "541892", "577957", "577961", "687043", "1009145"], "spl_set_id": ["9af67219-9b37-45d0-ac52-647cbfacd296"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (57664-641-08)", "package_ndc": "57664-641-08", "marketing_start_date": "20030909"}], "brand_name": "Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate", "product_id": "57664-641_177c0583-addd-49cc-e063-6394a90aa6cc", "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": "57664-641", "dea_schedule": "CII", "generic_name": "Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE", "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": "ANDA040480", "marketing_category": "ANDA", "marketing_start_date": "20030909", "listing_expiration_date": "20261231"}