lisdexamfetamine dimesylate

Generic: lisdexamfetamine dimesylate

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

Drug Facts

Product Profile

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

lisdexamfetamine dimesylate 10 mg/1

Manufacturer
Alvogen Inc.

Identifiers & Regulatory

Product NDC 47781-562
Product ID 47781-562_567bb281-4098-07f8-9503-92299dc1c4c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214547
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 47781562
Hyphenated Format 47781-562

Supplemental Identifiers

RxCUI
854830 854834 854838 854842 854846 854850 1593856
UPC
0347781568016 0347781564018 0347781567019 0347781562014 0347781563011 0347781565015 0347781566012
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 ANDA214547 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (47781-562-01)
source: ndc

Packages (1)

47781-562-01 100 CAPSULE in 1 BOTTLE (47781-562-01)

Ingredients (1)

lisdexamfetamine dimesylate (10 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": "567bb281-4098-07f8-9503-92299dc1c4c6", "openfda": {"upc": ["0347781568016", "0347781564018", "0347781567019", "0347781562014", "0347781563011", "0347781565015", "0347781566012"], "unii": ["SJT761GEGS"], "rxcui": ["854830", "854834", "854838", "854842", "854846", "854850", "1593856"], "spl_set_id": ["7f2dd6ee-3363-c87c-9693-ed838942556c"], "manufacturer_name": ["Alvogen Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (47781-562-01)", "package_ndc": "47781-562-01", "marketing_start_date": "20230825"}], "brand_name": "lisdexamfetamine dimesylate", "product_id": "47781-562_567bb281-4098-07f8-9503-92299dc1c4c6", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "47781-562", "dea_schedule": "CII", "generic_name": "lisdexamfetamine dimesylate", "labeler_name": "Alvogen Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lisdexamfetamine dimesylate", "active_ingredients": [{"name": "LISDEXAMFETAMINE DIMESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA214547", "marketing_category": "ANDA", "marketing_start_date": "20230825", "listing_expiration_date": "20261231"}