dextroamphetamine sulfate

Generic: dextroamphetamine sulfate

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dextroamphetamine sulfate 5 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-8958
Product ID 0406-8958_f843d278-cec1-438f-8d54-120524010ce9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040436
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2002-01-29

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 04068958
Hyphenated Format 0406-8958

Supplemental Identifiers

RxCUI
884385 884386
UPC
0304068958014 0304068959011
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 ANDA040436 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0406-8958-01)
source: ndc

Packages (1)

0406-8958-01 100 TABLET in 1 BOTTLE (0406-8958-01)

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": "f843d278-cec1-438f-8d54-120524010ce9", "openfda": {"upc": ["0304068958014", "0304068959011"], "unii": ["JJ768O327N"], "rxcui": ["884385", "884386"], "spl_set_id": ["e05cf690-d45a-4696-a1bf-40c9350cc084"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0406-8958-01)", "package_ndc": "0406-8958-01", "marketing_start_date": "20020129"}], "brand_name": "DEXTROAMPHETAMINE SULFATE", "product_id": "0406-8958_f843d278-cec1-438f-8d54-120524010ce9", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0406-8958", "dea_schedule": "CII", "generic_name": "dextroamphetamine sulfate", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXTROAMPHETAMINE SULFATE", "active_ingredients": [{"name": "DEXTROAMPHETAMINE SULFATE", "strength": "5 mg/1"}], "application_number": "ANDA040436", "marketing_category": "ANDA", "marketing_start_date": "20020129", "listing_expiration_date": "20261231"}