lisdexamfetamine dimesylate

Generic: lisdexamfetamine dimesylate capsules

Labeler: solco healthcare us,llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lisdexamfetamine dimesylate
Generic Name lisdexamfetamine dimesylate capsules
Labeler solco healthcare us,llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

lisdexamfetamine dimesylate 20 mg/1

Manufacturer
Solco Healthcare US,LLC

Identifiers & Regulatory

Product NDC 43547-603
Product ID 43547-603_c17f13ef-4b2e-4b45-aff9-e79a2e8a7d53
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216266
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2023-08-26

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 43547603
Hyphenated Format 43547-603

Supplemental Identifiers

RxCUI
854830 854834 854838 854842 854846 854850 1593856
UPC
0343547604103 0343547605100 0343547607104 0343547603106
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 capsules (source: ndc)
Application Number ANDA216266 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (43547-603-10)
source: ndc

Packages (1)

43547-603-10 100 CAPSULE in 1 BOTTLE (43547-603-10)

Ingredients (1)

lisdexamfetamine dimesylate (20 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": "c17f13ef-4b2e-4b45-aff9-e79a2e8a7d53", "openfda": {"upc": ["0343547604103", "0343547605100", "0343547607104", "0343547603106"], "unii": ["SJT761GEGS"], "rxcui": ["854830", "854834", "854838", "854842", "854846", "854850", "1593856"], "spl_set_id": ["68b10d9f-ca3e-493d-a309-45f1d7e08061"], "manufacturer_name": ["Solco Healthcare US,LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (43547-603-10)", "package_ndc": "43547-603-10", "marketing_start_date": "20230826"}], "brand_name": "Lisdexamfetamine dimesylate", "product_id": "43547-603_c17f13ef-4b2e-4b45-aff9-e79a2e8a7d53", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "43547-603", "dea_schedule": "CII", "generic_name": "Lisdexamfetamine dimesylate capsules", "labeler_name": "Solco Healthcare US,LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lisdexamfetamine dimesylate", "active_ingredients": [{"name": "LISDEXAMFETAMINE DIMESYLATE", "strength": "20 mg/1"}], "application_number": "ANDA216266", "marketing_category": "ANDA", "marketing_start_date": "20230826", "listing_expiration_date": "20261231"}