lisdexamfetamine dimesylate

Generic: lisdexamfetamine dimesylate

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lisdexamfetamine dimesylate
Generic Name lisdexamfetamine dimesylate
Labeler lannett company, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

lisdexamfetamine dimesylate 20 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-4662
Product ID 0527-4662_7ac942a6-689a-420b-87bf-dc59003400dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215802
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2023-08-25

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 05274662
Hyphenated Format 0527-4662

Supplemental Identifiers

RxCUI
854830 854834 854838 854842 854846 854850 1593856
UPC
0305274664379 0305274666373 0305274661378 0305274665376 0305274667370 0305274663372
UNII
SJT761GEGS

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 lisdexamfetamine dimesylate (source: ndc)
Generic Name lisdexamfetamine dimesylate (source: ndc)
Application Number ANDA215802 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0527-4662-37)
source: ndc

Packages (1)

0527-4662-37 100 CAPSULE in 1 BOTTLE (0527-4662-37)

Ingredients (1)

lisdexamfetamine dimesylate (20 mg/1)

Linked Drug Pages (1)

Lisdexamfetamine Dimesylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7ac942a6-689a-420b-87bf-dc59003400dc", "openfda": {"upc": ["0305274664379", "0305274666373", "0305274661378", "0305274665376", "0305274667370", "0305274663372"], "unii": ["SJT761GEGS"], "rxcui": ["854830", "854834", "854838", "854842", "854846", "854850", "1593856"], "spl_set_id": ["2cedb4c2-1e40-4bc4-b9f4-127150c4afbd"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0527-4662-37)", "package_ndc": "0527-4662-37", "marketing_start_date": "20230825"}], "brand_name": "Lisdexamfetamine Dimesylate", "product_id": "0527-4662_7ac942a6-689a-420b-87bf-dc59003400dc", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0527-4662", "dea_schedule": "CII", "generic_name": "Lisdexamfetamine Dimesylate", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lisdexamfetamine Dimesylate", "active_ingredients": [{"name": "LISDEXAMFETAMINE DIMESYLATE", "strength": "20 mg/1"}], "application_number": "ANDA215802", "marketing_category": "ANDA", "marketing_start_date": "20230825", "listing_expiration_date": "20261231"}