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 TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

lisdexamfetamine dimesylate 30 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-5126
Product ID 0406-5126_02215a03-fa4d-4785-9d38-4f22d92faf31
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218850
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 04065126
Hyphenated Format 0406-5126

Supplemental Identifiers

RxCUI
1871456 1871460 1871462 1871464 1871466 1871468
UPC
0304065125013 0304065128014 0304065126010 0304065127017 0304065129011 0304065124016
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 ANDA218850 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 TABLET, CHEWABLE in 1 BOTTLE (0406-5126-01)
source: ndc

Packages (1)

0406-5126-01 100 TABLET, CHEWABLE in 1 BOTTLE (0406-5126-01)

Ingredients (1)

lisdexamfetamine dimesylate (30 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": "02215a03-fa4d-4785-9d38-4f22d92faf31", "openfda": {"upc": ["0304065125013", "0304065128014", "0304065126010", "0304065127017", "0304065129011", "0304065124016"], "unii": ["SJT761GEGS"], "rxcui": ["1871456", "1871460", "1871462", "1871464", "1871466", "1871468"], "spl_set_id": ["3a79b2ab-4131-4978-99a0-0119df57d5fe"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (0406-5126-01)", "package_ndc": "0406-5126-01", "marketing_start_date": "20241217"}], "brand_name": "Lisdexamfetamine Dimesylate", "product_id": "0406-5126_02215a03-fa4d-4785-9d38-4f22d92faf31", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0406-5126", "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": "30 mg/1"}], "application_number": "ANDA218850", "marketing_category": "ANDA", "marketing_start_date": "20241217", "listing_expiration_date": "20261231"}