lisdexamfetamine dimesylate

Generic: lisdexamfetamine dimesylate

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

Drug Facts

Product Profile

Brand Name lisdexamfetamine dimesylate
Generic Name lisdexamfetamine dimesylate
Labeler granules pharmaceuticals inc.
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

lisdexamfetamine dimesylate 30 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-216
Product ID 70010-216_40a5b194-0781-0d28-e063-6294a90ab272
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219258
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 70010216
Hyphenated Format 70010-216

Supplemental Identifiers

RxCUI
1871456 1871460 1871462 1871464 1871466 1871468
UPC
0370010218017 0370010217010 0370010216013 0370010215016 0370010214019 0370010219014
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 ANDA219258 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 TABLET, CHEWABLE in 1 BOTTLE (70010-216-01)
source: ndc

Packages (1)

70010-216-01 100 TABLET, CHEWABLE in 1 BOTTLE (70010-216-01)

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": "40a5b194-0781-0d28-e063-6294a90ab272", "openfda": {"upc": ["0370010218017", "0370010217010", "0370010216013", "0370010215016", "0370010214019", "0370010219014"], "unii": ["SJT761GEGS"], "rxcui": ["1871456", "1871460", "1871462", "1871464", "1871466", "1871468"], "spl_set_id": ["c56b4712-2fb8-4c7a-bfbd-0401d9f5f92a"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (70010-216-01)", "package_ndc": "70010-216-01", "marketing_start_date": "20241217"}], "brand_name": "Lisdexamfetamine dimesylate", "product_id": "70010-216_40a5b194-0781-0d28-e063-6294a90ab272", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "70010-216", "dea_schedule": "CII", "generic_name": "Lisdexamfetamine dimesylate", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lisdexamfetamine dimesylate", "active_ingredients": [{"name": "LISDEXAMFETAMINE DIMESYLATE", "strength": "30 mg/1"}], "application_number": "ANDA219258", "marketing_category": "ANDA", "marketing_start_date": "20241217", "listing_expiration_date": "20261231"}