mixed salts of a single entity amphetamine product xr

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

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mixed salts of a single entity amphetamine product xr
Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
Labeler specgx llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

amphetamine aspartate monohydrate 5 mg/1, amphetamine sulfate 5 mg/1, dextroamphetamine saccharate 5 mg/1, dextroamphetamine sulfate 5 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-8954
Product ID 0406-8954_d35f2f82-b0de-4f2a-a740-3d95c364cd7b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211547
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-04-22

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 04068954
Hyphenated Format 0406-8954

Supplemental Identifiers

RxCUI
861221 861223 861225 861227 861232 861237
UPC
0304068956010 0304068955013
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 mixed salts of a single entity amphetamine product xr (source: ndc)
Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate (source: ndc)
Application Number ANDA211547 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8954-01)
source: ndc

Packages (1)

0406-8954-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8954-01)

Ingredients (4)

amphetamine aspartate monohydrate (5 mg/1) amphetamine sulfate (5 mg/1) dextroamphetamine saccharate (5 mg/1) dextroamphetamine sulfate (5 mg/1)

Linked Drug Pages (1)

Mixed Salts of a Single Entity Amphetamine Product XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d35f2f82-b0de-4f2a-a740-3d95c364cd7b", "openfda": {"upc": ["0304068956010", "0304068955013"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["861221", "861223", "861225", "861227", "861232", "861237"], "spl_set_id": ["60a2834c-38a2-480e-b89c-563e9cf0c9c3"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8954-01)", "package_ndc": "0406-8954-01", "marketing_start_date": "20190422"}], "brand_name": "Mixed Salts of a Single Entity Amphetamine Product XR", "product_id": "0406-8954_d35f2f82-b0de-4f2a-a740-3d95c364cd7b", "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": "0406-8954", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mixed Salts of a Single Entity Amphetamine Product", "brand_name_suffix": "XR", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE MONOHYDRATE", "strength": "5 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "5 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "5 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "5 mg/1"}], "application_number": "ANDA211547", "marketing_category": "ANDA", "marketing_start_date": "20190422", "listing_expiration_date": "20261231"}