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 CAPSULE
Routes
ORAL
Active Ingredients

lisdexamfetamine dimesylate 20 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-207
Product ID 70010-207_40cab3c8-ab54-904d-e063-6294a90a1e8d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218987
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2025-01-29

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 70010207
Hyphenated Format 70010-207

Supplemental Identifiers

RxCUI
854830 854834 854838 854842 854846 854850 1593856
UPC
0370010211018 0370010206014 0370010207011 0370010209015 0370010212015 0370010208018
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 ANDA218987 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (70010-207-01)
source: ndc

Packages (1)

70010-207-01 100 CAPSULE in 1 BOTTLE (70010-207-01)

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": "40cab3c8-ab54-904d-e063-6294a90a1e8d", "openfda": {"upc": ["0370010211018", "0370010206014", "0370010207011", "0370010209015", "0370010212015", "0370010208018"], "unii": ["SJT761GEGS"], "rxcui": ["854830", "854834", "854838", "854842", "854846", "854850", "1593856"], "spl_set_id": ["c91c6acf-b68c-4832-a06f-d0fbd6b80457"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (70010-207-01)", "package_ndc": "70010-207-01", "marketing_start_date": "20250129"}], "brand_name": "LISDEXAMFETAMINE DIMESYLATE", "product_id": "70010-207_40cab3c8-ab54-904d-e063-6294a90a1e8d", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "70010-207", "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": "20 mg/1"}], "application_number": "ANDA218987", "marketing_category": "ANDA", "marketing_start_date": "20250129", "listing_expiration_date": "20261231"}