dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (0185-2099)

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 sandoz inc

Dosage Form TABLET

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

Manufacturer

Sandoz Inc

Identifiers & Regulatory

Product NDC 0185-2099

Product ID 0185-2099_9a21fb59-a99c-4c63-91e8-4b5d72fbd9cd

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040439

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2002-06-14

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 01852099

Hyphenated Format 0185-2099

Supplemental Identifiers

RxCUI

541363 541878 541892 577961

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 and amphetamine sulfate (source: ndc)

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

Application Number ANDA040439 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

7.5 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (0185-2099-01)

source: ndc

Packages (1)

0185-2099-01 100 TABLET in 1 BOTTLE (0185-2099-01)

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": "9a21fb59-a99c-4c63-91e8-4b5d72fbd9cd", "openfda": {"unii": ["O1ZPV620O4", "6DPV8NK46S", "G83415V073", "JJ768O327N"], "rxcui": ["541363", "541878", "541892", "577961"], "spl_set_id": ["288dafc4-fe6e-4891-832f-511022c87445"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0185-2099-01)", "package_ndc": "0185-2099-01", "marketing_start_date": "20211116"}], "brand_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate", "product_id": "0185-2099_9a21fb59-a99c-4c63-91e8-4b5d72fbd9cd", "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": "0185-2099", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate", "labeler_name": "Sandoz 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": "ANDA040439", "marketing_category": "ANDA", "marketing_start_date": "20020614", "listing_expiration_date": "20261231"}