dextroamphetamine sulfate

Generic: dextroamphetamine sulfate

Labeler: sunrise pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextroamphetamine sulfate
Generic Name dextroamphetamine sulfate
Labeler sunrise pharmaceutical, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dextroamphetamine sulfate 5 mg/1

Manufacturer
SUNRISE PHARMACEUTICAL, INC.

Identifiers & Regulatory

Product NDC 11534-188
Product ID 11534-188_2c5c3b56-a600-4196-9e40-ae80e4586527
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210059
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 11534188
Hyphenated Format 11534-188

Supplemental Identifiers

RxCUI
884385 884386
UPC
0311534189032 0311534188035
UNII
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 sulfate (source: ndc)
Generic Name dextroamphetamine sulfate (source: ndc)
Application Number ANDA210059 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (11534-188-01)
  • 1000 TABLET in 1 BOTTLE (11534-188-03)
source: ndc

Packages (2)

11534-188-01 100 TABLET in 1 BOTTLE (11534-188-01) 11534-188-03 1000 TABLET in 1 BOTTLE (11534-188-03)

Ingredients (1)

dextroamphetamine sulfate (5 mg/1)

Linked Drug Pages (1)

DEXTROAMPHETAMINE SULFATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c5c3b56-a600-4196-9e40-ae80e4586527", "openfda": {"upc": ["0311534189032", "0311534188035"], "unii": ["JJ768O327N"], "rxcui": ["884385", "884386"], "spl_set_id": ["93b3a40f-b7ac-4047-8ff5-3e34c2d75193"], "manufacturer_name": ["SUNRISE PHARMACEUTICAL, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (11534-188-01)", "package_ndc": "11534-188-01", "marketing_start_date": "20180704"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (11534-188-03)", "package_ndc": "11534-188-03", "marketing_start_date": "20180704"}], "brand_name": "DEXTROAMPHETAMINE SULFATE", "product_id": "11534-188_2c5c3b56-a600-4196-9e40-ae80e4586527", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "11534-188", "dea_schedule": "CII", "generic_name": "dextroamphetamine sulfate", "labeler_name": "SUNRISE PHARMACEUTICAL, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXTROAMPHETAMINE SULFATE", "active_ingredients": [{"name": "DEXTROAMPHETAMINE SULFATE", "strength": "5 mg/1"}], "application_number": "ANDA210059", "marketing_category": "ANDA", "marketing_start_date": "20180704", "listing_expiration_date": "20261231"}