relexxii

Generic: methylphenidate hydrochloride

Labeler: vertical pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name relexxii
Generic Name methylphenidate hydrochloride
Labeler vertical pharmaceuticals, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 18 mg/1

Manufacturer
Vertical Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 68025-095
Product ID 68025-095_86f477e9-07fc-466b-913e-1a4434c91df4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216117
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2022-06-23

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 68025095
Hyphenated Format 68025-095

Supplemental Identifiers

RxCUI
1091155 1091170 1091185 1091210 1995461 2052826 2605796 2605798 2605943 2605946 2668496 2668499 2668502 2668505
UPC
0368025097109 0368025096300 0368025096102 0368025084307 0368025095303 0368025098304 0368025095105 0368025098106 0368025089302 0368025088305 0368025097307
UNII
4B3SC438HI

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 relexxii (source: ndc)
Generic Name methylphenidate hydrochloride (source: ndc)
Application Number NDA216117 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 18 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-095-10)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-095-30)
source: ndc

Packages (2)

68025-095-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-095-10) 68025-095-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-095-30)

Ingredients (1)

methylphenidate hydrochloride (18 mg/1)

Linked Drug Pages (1)

RELEXXII ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "86f477e9-07fc-466b-913e-1a4434c91df4", "openfda": {"upc": ["0368025097109", "0368025096300", "0368025096102", "0368025084307", "0368025095303", "0368025098304", "0368025095105", "0368025098106", "0368025089302", "0368025088305", "0368025097307"], "unii": ["4B3SC438HI"], "rxcui": ["1091155", "1091170", "1091185", "1091210", "1995461", "2052826", "2605796", "2605798", "2605943", "2605946", "2668496", "2668499", "2668502", "2668505"], "spl_set_id": ["22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d"], "manufacturer_name": ["Vertical Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-095-10)", "package_ndc": "68025-095-10", "marketing_start_date": "20231101"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-095-30)", "package_ndc": "68025-095-30", "marketing_start_date": "20240812"}], "brand_name": "RELEXXII", "product_id": "68025-095_86f477e9-07fc-466b-913e-1a4434c91df4", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "68025-095", "dea_schedule": "CII", "generic_name": "methylphenidate hydrochloride", "labeler_name": "Vertical Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RELEXXII", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "18 mg/1"}], "application_number": "NDA216117", "marketing_category": "NDA", "marketing_start_date": "20220623", "listing_expiration_date": "20261231"}