mixed salts of a single-entity amphetamine product

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

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-0805
Product ID 0406-0805_03d41c88-9c50-4406-91ba-7a086cad0366
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211546
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2023-11-01

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 04060805
Hyphenated Format 0406-0805

Supplemental Identifiers

RxCUI
1927610 1927617 1927630 1927637
UPC
0304060804012 0304060805019 0304060807013 0304060803015
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 (source: ndc)
Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate (source: ndc)
Application Number ANDA211546 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.125 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0805-01)
source: ndc

Packages (1)

0406-0805-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0805-01)

Ingredients (4)

amphetamine aspartate monohydrate (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)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "03d41c88-9c50-4406-91ba-7a086cad0366", "openfda": {"upc": ["0304060804012", "0304060805019", "0304060807013", "0304060803015"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["1927610", "1927617", "1927630", "1927637"], "spl_set_id": ["e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0805-01)", "package_ndc": "0406-0805-01", "marketing_start_date": "20231101"}], "brand_name": "Mixed Salts of a Single-Entity Amphetamine Product", "product_id": "0406-0805_03d41c88-9c50-4406-91ba-7a086cad0366", "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": "0406-0805", "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", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE MONOHYDRATE", "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": "ANDA211546", "marketing_category": "ANDA", "marketing_start_date": "20231101", "listing_expiration_date": "20261231"}