lisdexamfetamine dimesylate

Generic: lisdexamfetamine

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lisdexamfetamine dimesylate
Generic Name lisdexamfetamine
Labeler amneal pharmaceuticals llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

lisdexamfetamine dimesylate 70 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-028
Product ID 65162-028_5fde01e6-09ba-4a92-bd47-aad0d7c518e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202830
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2023-08-28

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 65162028
Hyphenated Format 65162-028

Supplemental Identifiers

RxCUI
854830 854834 854838 854842 854846 854850
UPC
0365162023091 0365162027099 0365162025095 0365162024098 0365162028096 0365162026092
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 (source: ndc)
Application Number ANDA202830 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 70 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (65162-028-09)
source: ndc

Packages (1)

65162-028-09 90 CAPSULE in 1 BOTTLE (65162-028-09)

Ingredients (1)

lisdexamfetamine dimesylate (70 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": "5fde01e6-09ba-4a92-bd47-aad0d7c518e4", "openfda": {"upc": ["0365162023091", "0365162027099", "0365162025095", "0365162024098", "0365162028096", "0365162026092"], "unii": ["SJT761GEGS"], "rxcui": ["854830", "854834", "854838", "854842", "854846", "854850"], "spl_set_id": ["c11cb3b6-3dff-477b-a249-b4c3118edc5f"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (65162-028-09)", "package_ndc": "65162-028-09", "marketing_start_date": "20230828"}], "brand_name": "Lisdexamfetamine Dimesylate", "product_id": "65162-028_5fde01e6-09ba-4a92-bd47-aad0d7c518e4", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "65162-028", "dea_schedule": "CII", "generic_name": "Lisdexamfetamine", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lisdexamfetamine Dimesylate", "active_ingredients": [{"name": "LISDEXAMFETAMINE DIMESYLATE", "strength": "70 mg/1"}], "application_number": "ANDA202830", "marketing_category": "ANDA", "marketing_start_date": "20230828", "listing_expiration_date": "20261231"}