lisdexamfetamine dimesylate

Generic: lisdexamfetamine dimesylate

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lisdexamfetamine dimesylate
Generic Name lisdexamfetamine dimesylate
Labeler novadoz pharmaceuticals llc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

lisdexamfetamine dimesylate 60 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-137
Product ID 72205-137_a79cb70c-0bfa-4d68-9a21-a5ef4bc3c811
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218306
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2024-02-02

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 72205137
Hyphenated Format 72205-137

Supplemental Identifiers

RxCUI
1871456 1871460 1871462 1871464 1871466 1871468
UPC
0372205133914 0372205137912 0372205135918 0372205134911 0372205136915 0372205132917
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 ANDA218306 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET, CHEWABLE in 1 BOTTLE (72205-137-91)
source: ndc

Packages (1)

72205-137-91 100 TABLET, CHEWABLE in 1 BOTTLE (72205-137-91)

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": "a79cb70c-0bfa-4d68-9a21-a5ef4bc3c811", "openfda": {"upc": ["0372205133914", "0372205137912", "0372205135918", "0372205134911", "0372205136915", "0372205132917"], "unii": ["SJT761GEGS"], "rxcui": ["1871456", "1871460", "1871462", "1871464", "1871466", "1871468"], "spl_set_id": ["a79cb70c-0bfa-4d68-9a21-a5ef4bc3c811"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (72205-137-91)", "package_ndc": "72205-137-91", "marketing_start_date": "20240217"}], "brand_name": "Lisdexamfetamine dimesylate", "product_id": "72205-137_a79cb70c-0bfa-4d68-9a21-a5ef4bc3c811", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "72205-137", "dea_schedule": "CII", "generic_name": "Lisdexamfetamine dimesylate", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lisdexamfetamine dimesylate", "active_ingredients": [{"name": "LISDEXAMFETAMINE DIMESYLATE", "strength": "60 mg/1"}], "application_number": "ANDA218306", "marketing_category": "ANDA", "marketing_start_date": "20240202", "listing_expiration_date": "20261231"}