dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

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

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

Drug Facts

Product Profile

Brand Name dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
Generic Name dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
Labeler granules pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amphetamine aspartate monohydrate 7.5 mg/1, amphetamine sulfate 7.5 mg/1, dextroamphetamine saccharate 7.5 mg/1, dextroamphetamine sulfate 7.5 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-117
Product ID 70010-117_2fab399e-2a43-5134-e063-6294a90ae09a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215771
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2023-03-28

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 70010117
Hyphenated Format 70010-117

Supplemental Identifiers

RxCUI
541363 541878 541892 577957 577961 687043 1009145
UPC
0370010117037 0370010113039 0370010111035 0370010116030 0370010115033
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, dextroamphetamine sulfate and amphetamine sulfate (source: ndc)
Application Number ANDA215771 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70010-117-01)
  • 30 TABLET in 1 BOTTLE (70010-117-03)
source: ndc

Packages (2)

70010-117-01 100 TABLET in 1 BOTTLE (70010-117-01) 70010-117-03 30 TABLET in 1 BOTTLE (70010-117-03)

Ingredients (4)

amphetamine aspartate monohydrate (7.5 mg/1) amphetamine sulfate (7.5 mg/1) dextroamphetamine saccharate (7.5 mg/1) dextroamphetamine sulfate (7.5 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": "2fab399e-2a43-5134-e063-6294a90ae09a", "openfda": {"upc": ["0370010117037", "0370010113039", "0370010111035", "0370010116030", "0370010115033"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["541363", "541878", "541892", "577957", "577961", "687043", "1009145"], "spl_set_id": ["b0b4eccc-34c7-483d-966f-82d588358e1b"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70010-117-01)", "package_ndc": "70010-117-01", "marketing_start_date": "20230328"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70010-117-03)", "package_ndc": "70010-117-03", "marketing_start_date": "20240430"}], "brand_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate", "product_id": "70010-117_2fab399e-2a43-5134-e063-6294a90ae09a", "dosage_form": "TABLET", "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": "70010-117", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate", "labeler_name": "Granules Pharmaceuticals 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": "7.5 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "7.5 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "7.5 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "7.5 mg/1"}], "application_number": "ANDA215771", "marketing_category": "ANDA", "marketing_start_date": "20230328", "listing_expiration_date": "20261231"}