dextroamphetamine sulfate

Generic: dextroamphetamine sulfate

Labeler: winder laboratories llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextroamphetamine sulfate
Generic Name dextroamphetamine sulfate
Labeler winder laboratories llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dextroamphetamine sulfate 5 mg/1

Manufacturer
Winder Laboratories LLC

Identifiers & Regulatory

Product NDC 75826-121
Product ID 75826-121_37ddfa9e-e495-a25f-e063-6394a90ac3d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212160
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2021-12-06

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 75826121
Hyphenated Format 75826-121

Supplemental Identifiers

RxCUI
884385 884386 884684 1425847 1425854 1535454 1535470
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 ANDA212160 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (75826-121-10)
  • 30 TABLET in 1 BOTTLE, PLASTIC (75826-121-30)
source: ndc

Packages (2)

75826-121-10 100 TABLET in 1 BOTTLE, PLASTIC (75826-121-10) 75826-121-30 30 TABLET in 1 BOTTLE, PLASTIC (75826-121-30)

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": "37ddfa9e-e495-a25f-e063-6394a90ac3d9", "openfda": {"unii": ["JJ768O327N"], "rxcui": ["884385", "884386", "884684", "1425847", "1425854", "1535454", "1535470"], "spl_set_id": ["ca1a8890-0675-4c9c-9716-6c28f975d827"], "manufacturer_name": ["Winder Laboratories LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (75826-121-10)", "package_ndc": "75826-121-10", "marketing_start_date": "20230324"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (75826-121-30)", "package_ndc": "75826-121-30", "marketing_start_date": "20230324"}], "brand_name": "Dextroamphetamine Sulfate", "product_id": "75826-121_37ddfa9e-e495-a25f-e063-6394a90ac3d9", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "75826-121", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Sulfate", "labeler_name": "Winder Laboratories LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine Sulfate", "active_ingredients": [{"name": "DEXTROAMPHETAMINE SULFATE", "strength": "5 mg/1"}], "application_number": "ANDA212160", "marketing_category": "ANDA", "marketing_start_date": "20211206", "listing_expiration_date": "20261231"}