lisdexamfetamine dimesylate

Generic: lisdexamfetamine dimesylate

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

Drug Facts

Product Profile

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

lisdexamfetamine dimesylate 30 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-323
Product ID 31722-323_37397df5-ba32-4489-a34b-81a61f5b860d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217068
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 31722323
Hyphenated Format 31722-323

Supplemental Identifiers

RxCUI
1871456 1871460 1871462 1871464 1871466 1871468
UPC
0331722324014 0331722323017 0331722322010 0331722325011 0331722321013 0331722326018
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 ANDA217068 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 TABLET, CHEWABLE in 1 BOTTLE (31722-323-01)
source: ndc

Packages (1)

31722-323-01 100 TABLET, CHEWABLE in 1 BOTTLE (31722-323-01)

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": "37397df5-ba32-4489-a34b-81a61f5b860d", "openfda": {"upc": ["0331722324014", "0331722323017", "0331722322010", "0331722325011", "0331722321013", "0331722326018"], "unii": ["SJT761GEGS"], "rxcui": ["1871456", "1871460", "1871462", "1871464", "1871466", "1871468"], "spl_set_id": ["f05bac63-08a5-49ce-8180-b33b76c0c0c4"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (31722-323-01)", "package_ndc": "31722-323-01", "marketing_start_date": "20230825"}], "brand_name": "LISDEXAMFETAMINE DIMESYLATE", "product_id": "31722-323_37397df5-ba32-4489-a34b-81a61f5b860d", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "31722-323", "dea_schedule": "CII", "generic_name": "lisdexamfetamine dimesylate", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LISDEXAMFETAMINE DIMESYLATE", "active_ingredients": [{"name": "LISDEXAMFETAMINE DIMESYLATE", "strength": "30 mg/1"}], "application_number": "ANDA217068", "marketing_category": "ANDA", "marketing_start_date": "20230825", "listing_expiration_date": "20261231"}