lisdexamfetamine dimesylate

Generic: lisdexamfetamine dimesylate

Labeler: elite laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lisdexamfetamine dimesylate
Generic Name lisdexamfetamine dimesylate
Labeler elite laboratories, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

lisdexamfetamine dimesylate 30 mg/1

Manufacturer
Elite Laboratories, Inc.

Identifiers & Regulatory

Product NDC 64850-552
Product ID 64850-552_81cfbfd5-71c0-4c39-bcf3-2eae9fbd48fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218604
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2024-11-15

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 64850552
Hyphenated Format 64850-552

Supplemental Identifiers

RxCUI
854830 854834 854838 854842 854846 854850 1593856
UPC
0364850552011 0364850550017 0364850553018 0364850556019 0364850555012 0364850551014 0364850554015
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 ANDA218604 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (64850-552-01)
source: ndc

Packages (1)

64850-552-01 100 CAPSULE in 1 BOTTLE (64850-552-01)

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": "81cfbfd5-71c0-4c39-bcf3-2eae9fbd48fa", "openfda": {"upc": ["0364850552011", "0364850550017", "0364850553018", "0364850556019", "0364850555012", "0364850551014", "0364850554015"], "unii": ["SJT761GEGS"], "rxcui": ["854830", "854834", "854838", "854842", "854846", "854850", "1593856"], "spl_set_id": ["0e024b69-567c-4b40-9c3e-a2daec34256c"], "manufacturer_name": ["Elite Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (64850-552-01)", "package_ndc": "64850-552-01", "marketing_start_date": "20241115"}], "brand_name": "Lisdexamfetamine Dimesylate", "product_id": "64850-552_81cfbfd5-71c0-4c39-bcf3-2eae9fbd48fa", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "64850-552", "dea_schedule": "CII", "generic_name": "lisdexamfetamine dimesylate", "labeler_name": "Elite Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lisdexamfetamine Dimesylate", "active_ingredients": [{"name": "LISDEXAMFETAMINE DIMESYLATE", "strength": "30 mg/1"}], "application_number": "ANDA218604", "marketing_category": "ANDA", "marketing_start_date": "20241115", "listing_expiration_date": "20261231"}