lisdexamfetamine dimesylate

Generic: lisdexamfetamine dimesylate

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lisdexamfetamine dimesylate
Generic Name lisdexamfetamine dimesylate
Labeler sandoz inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

lisdexamfetamine dimesylate 40 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-2478
Product ID 0781-2478_816921ba-16ab-4cdc-86e7-f21a86b03d1a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202836
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2025-09-16

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 07812478
Hyphenated Format 0781-2478

Supplemental Identifiers

RxCUI
854830 854834 854838 854842 854846 854850 1593856
UPC
0307812480014 0307812481011 0307812478011 0307812477014 0307812479018
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 ANDA202836 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0781-2478-01)
source: ndc

Packages (1)

0781-2478-01 100 CAPSULE in 1 BOTTLE (0781-2478-01)

Ingredients (1)

lisdexamfetamine dimesylate (40 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": "816921ba-16ab-4cdc-86e7-f21a86b03d1a", "openfda": {"upc": ["0307812480014", "0307812481011", "0307812478011", "0307812477014", "0307812479018"], "unii": ["SJT761GEGS"], "rxcui": ["854830", "854834", "854838", "854842", "854846", "854850", "1593856"], "spl_set_id": ["808cce3b-eee8-4f58-8d8a-53a4ce79ae7c"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0781-2478-01)", "package_ndc": "0781-2478-01", "marketing_start_date": "20250916"}], "brand_name": "Lisdexamfetamine dimesylate", "product_id": "0781-2478_816921ba-16ab-4cdc-86e7-f21a86b03d1a", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0781-2478", "dea_schedule": "CII", "generic_name": "Lisdexamfetamine dimesylate", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lisdexamfetamine dimesylate", "active_ingredients": [{"name": "LISDEXAMFETAMINE DIMESYLATE", "strength": "40 mg/1"}], "application_number": "ANDA202836", "marketing_category": "ANDA", "marketing_start_date": "20250916", "listing_expiration_date": "20261231"}