dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate

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

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate
Generic Name dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amphetamine dl-aspartate 5 mg/1, amphetamine sulfate 5 mg/1, dextroamphetamine saccharate 5 mg/1, dextroamphetamine sulfate 5 mg/1

Manufacturer
GLENMARK PHARMACEUTICALS INC., USA

Identifiers & Regulatory

Product NDC 68462-652
Product ID 68462-652_a586519f-97a3-4a3a-951a-c3ecaab95334
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210754
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2025-05-12

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 68462652
Hyphenated Format 68462-652

Supplemental Identifiers

RxCUI
541363 541878 541892 577957 577961
UPC
0368462651018 0368462649015 0368462652015 0368462647011 0368462653012
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, amphetamine sulfate (source: ndc)
Generic Name dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate (source: ndc)
Application Number ANDA210754 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68462-652-01)
source: ndc

Packages (1)

68462-652-01 100 TABLET in 1 BOTTLE (68462-652-01)

Ingredients (4)

amphetamine dl-aspartate (5 mg/1) amphetamine sulfate (5 mg/1) dextroamphetamine saccharate (5 mg/1) dextroamphetamine sulfate (5 mg/1)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a586519f-97a3-4a3a-951a-c3ecaab95334", "openfda": {"upc": ["0368462651018", "0368462649015", "0368462652015", "0368462647011", "0368462653012"], "unii": ["6DPV8NK46S", "G83415V073", "JJ768O327N", "H527KAP6L5"], "rxcui": ["541363", "541878", "541892", "577957", "577961"], "spl_set_id": ["4564e404-8d71-4585-ab78-55857f477143"], "manufacturer_name": ["GLENMARK PHARMACEUTICALS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68462-652-01)", "package_ndc": "68462-652-01", "marketing_start_date": "20250512"}], "brand_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate", "product_id": "68462-652_a586519f-97a3-4a3a-951a-c3ecaab95334", "dosage_form": "TABLET", "pharm_class": ["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]"], "product_ndc": "68462-652", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate", "labeler_name": "GLENMARK PHARMACEUTICALS INC., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate", "active_ingredients": [{"name": "AMPHETAMINE DL-ASPARTATE", "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": "ANDA210754", "marketing_category": "ANDA", "marketing_start_date": "20250512", "listing_expiration_date": "20271231"}