lisdexamfetamine dimesylate

Generic: lisdexamfetamine dimesylate

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

lisdexamfetamine dimesylate 60 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-5116
Product ID 0406-5116_b4be564a-404d-4ca1-bac0-ec9cf40fef93
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211840
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 04065116
Hyphenated Format 0406-5116

Supplemental Identifiers

RxCUI
854830 854834 854838 854842 854846 854850 1593856
UPC
0304065112013 0304065117018 0304065116011 0304065115014 0304065111016 0304065113010 0304065114017
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 ANDA211840 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0406-5116-01)
source: ndc

Packages (1)

0406-5116-01 100 CAPSULE in 1 BOTTLE (0406-5116-01)

Ingredients (1)

lisdexamfetamine dimesylate (60 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": "b4be564a-404d-4ca1-bac0-ec9cf40fef93", "openfda": {"upc": ["0304065112013", "0304065117018", "0304065116011", "0304065115014", "0304065111016", "0304065113010", "0304065114017"], "unii": ["SJT761GEGS"], "rxcui": ["854830", "854834", "854838", "854842", "854846", "854850", "1593856"], "spl_set_id": ["806a1c15-0842-4787-b2ad-09a21fd96b37"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0406-5116-01)", "package_ndc": "0406-5116-01", "marketing_start_date": "20230825"}], "brand_name": "Lisdexamfetamine Dimesylate", "product_id": "0406-5116_b4be564a-404d-4ca1-bac0-ec9cf40fef93", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0406-5116", "dea_schedule": "CII", "generic_name": "Lisdexamfetamine Dimesylate", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lisdexamfetamine Dimesylate", "active_ingredients": [{"name": "LISDEXAMFETAMINE DIMESYLATE", "strength": "60 mg/1"}], "application_number": "ANDA211840", "marketing_category": "ANDA", "marketing_start_date": "20230825", "listing_expiration_date": "20261231"}