lisdexamfetamine dimesylate

Generic: lisdexamfetamine

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

Drug Facts

Product Profile

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

lisdexamfetamine dimesylate 40 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-6857
Product ID 0378-6857_63cd6f7c-f976-440e-a35f-e71a9f2fd1bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202835
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 03786857
Hyphenated Format 0378-6857

Supplemental Identifiers

RxCUI
854830 854834 854838 854842 854846 854850 1593856
UPC
0303786859771
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 ANDA202835 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-6857-77)
source: ndc

Packages (1)

0378-6857-77 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-6857-77)

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": "63cd6f7c-f976-440e-a35f-e71a9f2fd1bb", "openfda": {"upc": ["0303786859771"], "unii": ["SJT761GEGS"], "rxcui": ["854830", "854834", "854838", "854842", "854846", "854850", "1593856"], "spl_set_id": ["efbde0f6-b848-4664-b741-c6c630e66108"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (0378-6857-77)", "package_ndc": "0378-6857-77", "marketing_start_date": "20230825"}], "brand_name": "Lisdexamfetamine Dimesylate", "product_id": "0378-6857_63cd6f7c-f976-440e-a35f-e71a9f2fd1bb", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0378-6857", "dea_schedule": "CII", "generic_name": "lisdexamfetamine", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lisdexamfetamine Dimesylate", "active_ingredients": [{"name": "LISDEXAMFETAMINE DIMESYLATE", "strength": "40 mg/1"}], "application_number": "ANDA202835", "marketing_category": "ANDA", "marketing_start_date": "20230825", "listing_expiration_date": "20261231"}