dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate (57664-953)

Drug Facts

Product Profile

Brand Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate

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

Labeler sun pharmaceutical industries, inc.

Dosage Form CAPSULE, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

amphetamine aspartate monohydrate 12.5 mg/1, amphetamine sulfate 12.5 mg/1, dextroamphetamine saccharate 12.5 mg/1, dextroamphetamine sulfate 12.5 mg/1

Manufacturer

Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-953

Product ID 57664-953_10af8563-97ec-8a5e-e063-6394a90a52f8

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA215997

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2024-02-01

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 57664953

Hyphenated Format 57664-953

Supplemental Identifiers

RxCUI

1927610 1927617 1927630 1927637

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 monohydrate, dextroamphetamine sulfate, amphetamine sulfate (source: ndc)

Generic Name dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate (source: ndc)

Application Number ANDA215997 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1

source: ndc

Packaging

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (57664-953-88)

source: ndc

Packages (1)

57664-953-88 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (57664-953-88)

Ingredients (4)

amphetamine aspartate monohydrate (12.5 mg/1) amphetamine sulfate (12.5 mg/1) dextroamphetamine saccharate (12.5 mg/1) dextroamphetamine sulfate (12.5 mg/1)

Linked Drug Pages (1)

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "10af8563-97ec-8a5e-e063-6394a90a52f8", "openfda": {"unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["1927610", "1927617", "1927630", "1927637"], "spl_set_id": ["30e515c3-a18f-499a-87c4-be8d64cfdbc6"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (57664-953-88)", "package_ndc": "57664-953-88", "marketing_start_date": "20240201"}], "brand_name": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate", "product_id": "57664-953_10af8563-97ec-8a5e-e063-6394a90a52f8", "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": "57664-953", "dea_schedule": "CII", "generic_name": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate", "active_ingredients": [{"name": "AMPHETAMINE ASPARTATE MONOHYDRATE", "strength": "12.5 mg/1"}, {"name": "AMPHETAMINE SULFATE", "strength": "12.5 mg/1"}, {"name": "DEXTROAMPHETAMINE SACCHARATE", "strength": "12.5 mg/1"}, {"name": "DEXTROAMPHETAMINE SULFATE", "strength": "12.5 mg/1"}], "application_number": "ANDA215997", "marketing_category": "ANDA", "marketing_start_date": "20240201", "listing_expiration_date": "20261231"}