lisdexamfetamine dimesylate

Generic: lisdexamfetamine dimesylate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lisdexamfetamine dimesylate
Generic Name lisdexamfetamine dimesylate
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

lisdexamfetamine dimesylate 50 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-050
Product ID 57664-050_0b77417a-5789-8818-e063-6294a90ad2e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214484
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2023-08-25

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 57664050
Hyphenated Format 57664-050

Supplemental Identifiers

RxCUI
854830 854834 854838 854842 854846 854850 1593856 1871456 1871460 1871462 1871464 1871466 1871468
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 ANDA214484 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (57664-050-88)
source: ndc

Packages (1)

57664-050-88 100 CAPSULE in 1 BOTTLE (57664-050-88)

Ingredients (1)

lisdexamfetamine dimesylate (50 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": "0b77417a-5789-8818-e063-6294a90ad2e3", "openfda": {"unii": ["SJT761GEGS"], "rxcui": ["854830", "854834", "854838", "854842", "854846", "854850", "1593856", "1871456", "1871460", "1871462", "1871464", "1871466", "1871468"], "spl_set_id": ["da3148af-f9b6-4725-adae-3595b4c7dc4b"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (57664-050-88)", "package_ndc": "57664-050-88", "marketing_start_date": "20230825"}], "brand_name": "LISDEXAMFETAMINE DIMESYLATE", "product_id": "57664-050_0b77417a-5789-8818-e063-6294a90ad2e3", "dosage_form": "CAPSULE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "57664-050", "dea_schedule": "CII", "generic_name": "LISDEXAMFETAMINE DIMESYLATE", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LISDEXAMFETAMINE DIMESYLATE", "active_ingredients": [{"name": "LISDEXAMFETAMINE DIMESYLATE", "strength": "50 mg/1"}], "application_number": "ANDA214484", "marketing_category": "ANDA", "marketing_start_date": "20230825", "listing_expiration_date": "20261231"}