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

Generic: dextroamphetamine saccharate, amphetamine aspartate monohydrate, 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 monohydrate, dextroamphetamine sulfate and amphetamine sulfate
Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate
Labeler granules pharmaceuticals 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
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-031
Product ID 70010-031_40cbcbf0-8e41-789e-e063-6294a90ab711
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217027
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2023-02-20

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 70010031
Hyphenated Format 70010-031

Supplemental Identifiers

RxCUI
861221 861223 861225 861227 861232 861237
UPC
0370010029019 0370010030015 0370010032019 0370010034013 0370010031012 0370010033016
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 monohydrate, dextroamphetamine sulfate and amphetamine sulfate (source: ndc)
Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (source: ndc)
Application Number ANDA217027 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.75 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-031-01)
source: ndc

Packages (1)

70010-031-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-031-01)

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 monohydrate, dextroamphetamine sulfate and amphetamine sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40cbcbf0-8e41-789e-e063-6294a90ab711", "openfda": {"upc": ["0370010029019", "0370010030015", "0370010032019", "0370010034013", "0370010031012", "0370010033016"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["861221", "861223", "861225", "861227", "861232", "861237"], "spl_set_id": ["8c672e06-0778-4a7d-b398-5bcbf2a73f12"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-031-01)", "package_ndc": "70010-031-01", "marketing_start_date": "20230220"}], "brand_name": "dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate", "product_id": "70010-031_40cbcbf0-8e41-789e-e063-6294a90ab711", "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": "70010-031", "dea_schedule": "CII", "generic_name": "dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "dextroamphetamine saccharate, amphetamine aspartate monohydrate, 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": "ANDA217027", "marketing_category": "ANDA", "marketing_start_date": "20230220", "listing_expiration_date": "20261231"}