dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate (16714-805)

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 northstar rx llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

amphetamine aspartate 3.125 mg/1, amphetamine sulfate 3.125 mg/1, dextroamphetamine saccharate 3.125 mg/1, dextroamphetamine sulfate 3.125 mg/1

Manufacturer

Northstar Rx LLC

Identifiers & Regulatory

Product NDC 16714-805

Product ID 16714-805_0e86a41d-6f4d-238f-e063-6294a90a8ab2

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040480

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2003-09-09

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 16714805

Hyphenated Format 16714-805

Supplemental Identifiers

RxCUI

541363 541878 541892 577957 577961 687043 1009145

UPC

0316714803012 0316714807010 0316714806013 0316714804019 0316714805016 0316714808017

UNII

6DPV8NK46S G83415V073 JJ768O327N H527KAP6L5

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 ANDA040480 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

3.125 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE, PLASTIC (16714-805-01)

source: ndc

Packages (1)

16714-805-01 100 TABLET in 1 BOTTLE, PLASTIC (16714-805-01)

Ingredients (4)

amphetamine aspartate (3.125 mg/1) amphetamine sulfate (3.125 mg/1) dextroamphetamine saccharate (3.125 mg/1) dextroamphetamine sulfate (3.125 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": "0e86a41d-6f4d-238f-e063-6294a90a8ab2", "openfda": {"upc": ["0316714803012", "0316714807010", "0316714806013", "0316714804019", "0316714805016", "0316714808017"], "unii": ["6DPV8NK46S", "G83415V073", "JJ768O327N", "H527KAP6L5"], "rxcui": ["541363", "541878", "541892", "577957", "577961", "687043", "1009145"], "spl_set_id": ["facdf159-1d95-4981-a8ad-d82edcc14a0c"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (16714-805-01)", "package_ndc": "16714-805-01", "marketing_start_date": "20030909"}], "brand_name": "Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate", "product_id": "16714-805_0e86a41d-6f4d-238f-e063-6294a90a8ab2", "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": "16714-805", "dea_schedule": "CII", "generic_name": "Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate", "labeler_name": "Northstar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE", "strength": "3.125 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "3.125 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "3.125 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "3.125 mg/1"}], "application_number": "ANDA040480", "marketing_category": "ANDA", "marketing_start_date": "20030909", "listing_expiration_date": "20261231"}