dextroamphetamine sulfate

Generic: dextroamphetamine sulfate

Labeler: aurolife pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextroamphetamine sulfate
Generic Name dextroamphetamine sulfate
Labeler aurolife pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dextroamphetamine sulfate 5 mg/1

Manufacturer
Aurolife Pharma, LLC

Identifiers & Regulatory

Product NDC 13107-035
Product ID 13107-035_a0c002da-f6e9-4979-af9b-5ca20118bc43
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202893
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2013-07-31

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 13107035
Hyphenated Format 13107-035

Supplemental Identifiers

RxCUI
884385 884386
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 ANDA202893 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (13107-035-01)
  • 50 TABLET in 1 BOTTLE (13107-035-50)
  • 1000 TABLET in 1 BOTTLE (13107-035-99)
source: ndc

Packages (3)

13107-035-01 100 TABLET in 1 BOTTLE (13107-035-01) 13107-035-50 50 TABLET in 1 BOTTLE (13107-035-50) 13107-035-99 1000 TABLET in 1 BOTTLE (13107-035-99)

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": "a0c002da-f6e9-4979-af9b-5ca20118bc43", "openfda": {"unii": ["JJ768O327N"], "rxcui": ["884385", "884386"], "spl_set_id": ["24163442-dd03-4066-a6ed-eb7e292b700b"], "manufacturer_name": ["Aurolife Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13107-035-01)", "package_ndc": "13107-035-01", "marketing_start_date": "20130731"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE (13107-035-50)", "package_ndc": "13107-035-50", "marketing_start_date": "20130731"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (13107-035-99)", "package_ndc": "13107-035-99", "marketing_start_date": "20130731"}], "brand_name": "DEXTROAMPHETAMINE SULFATE", "product_id": "13107-035_a0c002da-f6e9-4979-af9b-5ca20118bc43", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "13107-035", "dea_schedule": "CII", "generic_name": "DEXTROAMPHETAMINE SULFATE", "labeler_name": "Aurolife Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXTROAMPHETAMINE SULFATE", "active_ingredients": [{"name": "DEXTROAMPHETAMINE SULFATE", "strength": "5 mg/1"}], "application_number": "ANDA202893", "marketing_category": "ANDA", "marketing_start_date": "20130731", "listing_expiration_date": "20261231"}