dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

Generic: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
Labeler sandoz inc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

amphetamine aspartate monohydrate 3.75 mg/1, amphetamine sulfate 3.75 mg/1, dextroamphetamine saccharate 3.75 mg/1, dextroamphetamine sulfate 3.75 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-2343
Product ID 0781-2343_11936c1c-41a8-481c-b12f-dcc5837968d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021303
DEA Schedule cii
Marketing Start 2009-04-02
Marketing End 2027-04-30

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 07812343
Hyphenated Format 0781-2343

Supplemental Identifiers

RxCUI
861221 861223 861225 861227 861232 861237
UPC
0307812352014 0307812335017 0307812343012 0307812368015 0307812371015 0307812329016
UNII
O1ZPV620O4 6DPV8NK46S G83415V073 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 saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate (source: ndc)
Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate (source: ndc)
Application Number NDA021303 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.75 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2343-01)
source: ndc

Packages (1)

0781-2343-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2343-01)

Ingredients (4)

amphetamine aspartate monohydrate (3.75 mg/1) amphetamine sulfate (3.75 mg/1) dextroamphetamine saccharate (3.75 mg/1) dextroamphetamine sulfate (3.75 mg/1)

Linked Drug Pages (1)

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "11936c1c-41a8-481c-b12f-dcc5837968d2", "openfda": {"upc": ["0307812352014", "0307812335017", "0307812343012", "0307812368015", "0307812371015", "0307812329016"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["861221", "861223", "861225", "861227", "861232", "861237"], "spl_set_id": ["6f637e8d-7c2e-47fa-a43c-3250c51aed77"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2343-01)", "package_ndc": "0781-2343-01", "marketing_end_date": "20270430", "marketing_start_date": "20090402"}], "brand_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate", "product_id": "0781-2343_11936c1c-41a8-481c-b12f-dcc5837968d2", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Central Nervous System Stimulation [PE]", "Central Nervous System Stimulation [PE]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0781-2343", "dea_schedule": "CII", "generic_name": "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE MONOHYDRATE", "strength": "3.75 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "3.75 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "3.75 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "3.75 mg/1"}], "application_number": "NDA021303", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20270430", "marketing_start_date": "20090402"}