lisdexamfetamine dimesylate

Generic: lisdexamfetamine dimesylate

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

Drug Facts

Product Profile

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

lisdexamfetamine dimesylate 60 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-9744
Product ID 0480-9744_a9418850-010a-4fff-9aa7-d7167d58d8b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215415
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2024-09-16

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 04809744
Hyphenated Format 0480-9744

Supplemental Identifiers

RxCUI
1871456 1871460 1871462 1871464 1871466 1871468
UPC
0304809739018 0304809741011 0304809744012 0304809742018 0304809738011 0304809737014
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 ANDA215415 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET, CHEWABLE in 1 BOTTLE (0480-9744-01)
source: ndc

Packages (1)

0480-9744-01 100 TABLET, CHEWABLE in 1 BOTTLE (0480-9744-01)

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": "a9418850-010a-4fff-9aa7-d7167d58d8b6", "openfda": {"upc": ["0304809739018", "0304809741011", "0304809744012", "0304809742018", "0304809738011", "0304809737014"], "unii": ["SJT761GEGS"], "rxcui": ["1871456", "1871460", "1871462", "1871464", "1871466", "1871468"], "spl_set_id": ["bdb03bfa-0398-41e5-8e73-ded696cbca32"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (0480-9744-01)", "package_ndc": "0480-9744-01", "marketing_start_date": "20240916"}], "brand_name": "lisdexamfetamine dimesylate", "product_id": "0480-9744_a9418850-010a-4fff-9aa7-d7167d58d8b6", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0480-9744", "dea_schedule": "CII", "generic_name": "lisdexamfetamine dimesylate", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lisdexamfetamine dimesylate", "active_ingredients": [{"name": "LISDEXAMFETAMINE DIMESYLATE", "strength": "60 mg/1"}], "application_number": "ANDA215415", "marketing_category": "ANDA", "marketing_start_date": "20240916", "listing_expiration_date": "20261231"}