dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate tablets,cii

Generic: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate tablets, 5 mg,cll

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

Drug Facts

Product Profile

Brand Name dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate tablets,cii
Generic Name dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate tablets, 5 mg,cll
Labeler alvogen inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amphetamine aspartate monohydrate 1.25 mg/1, amphetamine sulfate 1.25 mg/1, dextroamphetamine saccharate 1.25 mg/1, dextroamphetamine sulfate 1.25 mg/1

Manufacturer
Alvogen Inc.

Identifiers & Regulatory

Product NDC 47781-174
Product ID 47781-174_0374f0f7-9297-810c-38b3-623a72709a7d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207388
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2017-07-28

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 47781174
Hyphenated Format 47781-174

Supplemental Identifiers

RxCUI
541363 541878 541892 577957 577961 687043 1009145
UPC
0347781176013 0347781177010 0347781178017 0347781174019 0347781179014 0347781175016 0347781180010
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, amphetamine sulfate tablets,cii (source: ndc)
Generic Name dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate tablets, 5 mg,cll (source: ndc)
Application Number ANDA207388 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (47781-174-01)
source: ndc

Packages (1)

47781-174-01 100 TABLET in 1 BOTTLE (47781-174-01)

Ingredients (4)

amphetamine aspartate monohydrate (1.25 mg/1) amphetamine sulfate (1.25 mg/1) dextroamphetamine saccharate (1.25 mg/1) dextroamphetamine sulfate (1.25 mg/1)

Linked Drug Pages (1)

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0374f0f7-9297-810c-38b3-623a72709a7d", "openfda": {"upc": ["0347781176013", "0347781177010", "0347781178017", "0347781174019", "0347781179014", "0347781175016", "0347781180010"], "unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["541363", "541878", "541892", "577957", "577961", "687043", "1009145"], "spl_set_id": ["c907301d-e24d-9609-5529-fed14f94549f"], "manufacturer_name": ["Alvogen Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (47781-174-01)", "package_ndc": "47781-174-01", "marketing_start_date": "20170728"}], "brand_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII", "product_id": "47781-174_0374f0f7-9297-810c-38b3-623a72709a7d", "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": "47781-174", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 5 mg,Cll", "labeler_name": "Alvogen Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE MONOHYDRATE", "strength": "1.25 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "1.25 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "1.25 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "1.25 mg/1"}], "application_number": "ANDA207388", "marketing_category": "ANDA", "marketing_start_date": "20170728", "listing_expiration_date": "20261231"}