dextroamphetamine sulfate

Generic: dextroamphetamine sulfate

Labeler: wilshire pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dextroamphetamine sulfate 5 mg/1

Manufacturer
Wilshire Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 52536-500
Product ID 52536-500_3777bded-3f46-0856-e063-6394a90a47b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090533
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2012-07-16

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 52536500
Hyphenated Format 52536-500

Supplemental Identifiers

RxCUI
884385 884386 884684 1535454 1535470
UPC
0352536520034 0352536510035 0352536515030 0352536530033 0352536500036
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 ANDA090533 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (52536-500-01)
  • 30 TABLET in 1 BOTTLE (52536-500-03)
source: ndc

Packages (2)

52536-500-01 100 TABLET in 1 BOTTLE (52536-500-01) 52536-500-03 30 TABLET in 1 BOTTLE (52536-500-03)

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": "3777bded-3f46-0856-e063-6394a90a47b4", "openfda": {"upc": ["0352536520034", "0352536510035", "0352536515030", "0352536530033", "0352536500036"], "unii": ["JJ768O327N"], "rxcui": ["884385", "884386", "884684", "1535454", "1535470"], "spl_set_id": ["6b8c97ac-c83c-4a1f-a33c-121239253abf"], "manufacturer_name": ["Wilshire Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (52536-500-01)", "package_ndc": "52536-500-01", "marketing_start_date": "20120716"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (52536-500-03)", "package_ndc": "52536-500-03", "marketing_start_date": "20210414"}], "brand_name": "Dextroamphetamine Sulfate", "product_id": "52536-500_3777bded-3f46-0856-e063-6394a90a47b4", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "52536-500", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Sulfate", "labeler_name": "Wilshire Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine Sulfate", "active_ingredients": [{"name": "DEXTROAMPHETAMINE SULFATE", "strength": "5 mg/1"}], "application_number": "ANDA090533", "marketing_category": "ANDA", "marketing_start_date": "20120716", "listing_expiration_date": "20261231"}