dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

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

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

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 ani pharmaceuticals, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

amphetamine dl-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
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43975-282
Product ID 43975-282_d0db10e9-cc85-492d-9f29-663948539b07
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205401
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-03-16

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 43975282
Hyphenated Format 43975-282

Supplemental Identifiers

RxCUI
861221 861223 861225 861227 861232 861237
UPC
0343975282102 0343975281105 0343975278105 0343975280108 0343975277108 0343975279102
UNII
6DPV8NK46S G83415V073 O1ZPV620O4 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 ANDA205401 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-282-10)
source: ndc

Packages (1)

43975-282-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-282-10)

Ingredients (4)

amphetamine dl-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": "d0db10e9-cc85-492d-9f29-663948539b07", "openfda": {"upc": ["0343975282102", "0343975281105", "0343975278105", "0343975280108", "0343975277108", "0343975279102"], "unii": ["6DPV8NK46S", "G83415V073", "O1ZPV620O4", "JJ768O327N"], "rxcui": ["861221", "861223", "861225", "861227", "861232", "861237"], "spl_set_id": ["6438480f-1147-42b6-826d-4e1e1f8ff007"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-282-10)", "package_ndc": "43975-282-10", "marketing_start_date": "20200316"}], "brand_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate", "product_id": "43975-282_d0db10e9-cc85-492d-9f29-663948539b07", "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": "43975-282", "dea_schedule": "CII", "generic_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate", "active_ingredients": [{"name": "AMPHETAMINE DL-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": "ANDA205401", "marketing_category": "ANDA", "marketing_start_date": "20200316", "listing_expiration_date": "20261231"}