Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (51407-553)

Drug Facts

Product Profile

Brand Name Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate

Generic Name Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate

Labeler Golden State Medical Supply, Inc.

Dosage Form CAPSULE, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

AMPHETAMINE ASPARTATE MONOHYDRATE 7.5 mg/1, AMPHETAMINE SULFATE 7.5 mg/1, DEXTROAMPHETAMINE SACCHARATE 7.5 mg/1, DEXTROAMPHETAMINE SULFATE 7.5 mg/1

Identifiers & Regulatory

Product NDC 51407-553

Product ID 51407-553_3a3c6a38-1dde-ada7-e063-6394a90a9cd1

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212037

DEA Schedule CII

Marketing Start 2019-12-11

Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51407553

Hyphenated Format 51407-553

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 Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (source: ndc)

Generic Name Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (source: ndc)

Application Number ANDA212037 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

7.5 mg/1

source: ndc

Packaging

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-553-01)

source: ndc

Packages (1)

51407-553-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-553-01)

Ingredients (4)

AMPHETAMINE ASPARTATE MONOHYDRATE (7.5 mg/1) AMPHETAMINE SULFATE (7.5 mg/1) DEXTROAMPHETAMINE SACCHARATE (7.5 mg/1) DEXTROAMPHETAMINE SULFATE (7.5 mg/1)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3a3c6a38-1dde-ada7-e063-6394a90a9cd1", "openfda": {"unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["861221", "861223", "861225", "861227", "861232", "861237"], "spl_set_id": ["b56d33c4-5359-e735-e053-2a95a90af67a"], "manufacturer_name": ["Golden State Medical Supply, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-553-01)", "package_ndc": "51407-553-01", "marketing_end_date": "20260228", "marketing_start_date": "20201119"}], "brand_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate", "product_id": "51407-553_3a3c6a38-1dde-ada7-e063-6394a90a9cd1", "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": "51407-553", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate", "labeler_name": "Golden State Medical Supply, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE MONOHYDRATE", "strength": "7.5 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "7.5 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "7.5 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "7.5 mg/1"}], "application_number": "ANDA212037", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20191211"}