dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

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

Labeler: sunrise pharmaceutical, 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 sunrise pharmaceutical, inc.
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
SUNRISE PHARMACEUTICAL, INC.

Identifiers & Regulatory

Product NDC 11534-193
Product ID 11534-193_86a00bec-51eb-4d73-a945-b1937970b29a
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 11534193
Hyphenated Format 11534-193

Supplemental Identifiers

RxCUI
541363 541878 541892 577957 577961 687043 1009145
UPC
0311534193039 0311534192032 0311534191035 0311534196016 0311534190038 0311534196030 0311534195033
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 ANDA209799 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.125 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (11534-193-01)
  • 1000 TABLET in 1 BOTTLE (11534-193-03)
source: ndc

Packages (2)

11534-193-01 100 TABLET in 1 BOTTLE (11534-193-01) 11534-193-03 1000 TABLET in 1 BOTTLE (11534-193-03)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "86a00bec-51eb-4d73-a945-b1937970b29a", "openfda": {"upc": ["0311534193039", "0311534192032", "0311534191035", "0311534196016", "0311534190038", "0311534196030", "0311534195033"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["541363", "541878", "541892", "577957", "577961", "687043", "1009145"], "spl_set_id": ["ac102599-3a5b-4154-899e-6ff262be7ff7"], "manufacturer_name": ["SUNRISE PHARMACEUTICAL, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (11534-193-01)", "package_ndc": "11534-193-01", "marketing_start_date": "20180704"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (11534-193-03)", "package_ndc": "11534-193-03", "marketing_start_date": "20180704"}], "brand_name": "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE", "product_id": "11534-193_86a00bec-51eb-4d73-a945-b1937970b29a", "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": "11534-193", "dea_schedule": "CII", "generic_name": "dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate", "labeler_name": "SUNRISE PHARMACEUTICAL, 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": "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": "ANDA209799", "marketing_category": "ANDA", "marketing_start_date": "20180704", "listing_expiration_date": "20261231"}