lisdexamfetamine dimesylate

Generic: lisdexamfetamine dimesylate

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

Drug Facts

Product Profile

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

lisdexamfetamine dimesylate 20 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-3566
Product ID 0480-3566_ded5754b-2e33-48b2-95cb-fb9457ea95c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202802
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2024-12-17

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 04803566
Hyphenated Format 0480-3566

Supplemental Identifiers

RxCUI
854830 854834 854838 854842 854846 854850 1593856
UPC
0304803567013 0304803570013 0304803569017 0304803566016 0304803565019
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 ANDA202802 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0480-3566-01)
source: ndc

Packages (1)

0480-3566-01 100 CAPSULE in 1 BOTTLE (0480-3566-01)

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": "ded5754b-2e33-48b2-95cb-fb9457ea95c6", "openfda": {"upc": ["0304803567013", "0304803570013", "0304803569017", "0304803566016", "0304803565019"], "unii": ["SJT761GEGS"], "rxcui": ["854830", "854834", "854838", "854842", "854846", "854850", "1593856"], "spl_set_id": ["c32b5dce-2de4-4db0-a4ba-d2ce3b0a32fc"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0480-3566-01)", "package_ndc": "0480-3566-01", "marketing_start_date": "20241217"}], "brand_name": "Lisdexamfetamine dimesylate", "product_id": "0480-3566_ded5754b-2e33-48b2-95cb-fb9457ea95c6", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0480-3566", "dea_schedule": "CII", "generic_name": "Lisdexamfetamine dimesylate", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lisdexamfetamine dimesylate", "active_ingredients": [{"name": "LISDEXAMFETAMINE DIMESYLATE", "strength": "20 mg/1"}], "application_number": "ANDA202802", "marketing_category": "ANDA", "marketing_start_date": "20241217", "listing_expiration_date": "20261231"}