dextroamphetamine sulfate

Generic: dextroamphetamine sulfate

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

Drug Facts

Product Profile

Brand Name dextroamphetamine sulfate
Generic Name dextroamphetamine sulfate
Labeler lupin pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dextroamphetamine sulfate 5 mg/1

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-870
Product ID 43386-870_fe1d7b03-a5d0-4a7c-99ad-7aca6edb5d02
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204330
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2016-04-25

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 43386870
Hyphenated Format 43386-870

Supplemental Identifiers

RxCUI
884385 884386
UPC
0343386871018 0343386870035
UNII
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 sulfate (source: ndc)
Generic Name dextroamphetamine sulfate (source: ndc)
Application Number ANDA204330 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (43386-870-01)
source: ndc

Packages (1)

43386-870-01 100 TABLET in 1 BOTTLE (43386-870-01)

Ingredients (1)

dextroamphetamine sulfate (5 mg/1)

Linked Drug Pages (1)

Dextroamphetamine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fe1d7b03-a5d0-4a7c-99ad-7aca6edb5d02", "openfda": {"upc": ["0343386871018", "0343386870035"], "unii": ["JJ768O327N"], "rxcui": ["884385", "884386"], "spl_set_id": ["9aea6b7c-729c-484d-b625-c3591b63b350"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (43386-870-01)", "package_ndc": "43386-870-01", "marketing_start_date": "20160425"}], "brand_name": "Dextroamphetamine Sulfate", "product_id": "43386-870_fe1d7b03-a5d0-4a7c-99ad-7aca6edb5d02", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "43386-870", "dea_schedule": "CII", "generic_name": "dextroamphetamine sulfate", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextroamphetamine Sulfate", "active_ingredients": [{"name": "DEXTROAMPHETAMINE SULFATE", "strength": "5 mg/1"}], "application_number": "ANDA204330", "marketing_category": "ANDA", "marketing_start_date": "20160425", "listing_expiration_date": "20261231"}