dexmethylphenidate hydrochloride extended-release

Generic: dexmethylphenidate hydrochloride

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexmethylphenidate hydrochloride extended-release
Generic Name dexmethylphenidate hydrochloride
Labeler lannett company, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dexmethylphenidate hydrochloride 20 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-8109
Product ID 0527-8109_05dde601-77db-4253-be20-c4737687633e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210279
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2018-10-09

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 05278109
Hyphenated Format 0527-8109

Supplemental Identifiers

RxCUI
899439 899461 899485 899495 899511 1006608 1101926 1101932
UPC
0305278113378
UNII
1678OK0E08

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 dexmethylphenidate hydrochloride extended-release (source: ndc)
Generic Name dexmethylphenidate hydrochloride (source: ndc)
Application Number ANDA210279 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-8109-37)
source: ndc

Packages (1)

0527-8109-37 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-8109-37)

Ingredients (1)

dexmethylphenidate hydrochloride (20 mg/1)

Linked Drug Pages (1)

Dexmethylphenidate Hydrochloride Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "05dde601-77db-4253-be20-c4737687633e", "openfda": {"upc": ["0305278113378"], "unii": ["1678OK0E08"], "rxcui": ["899439", "899461", "899485", "899495", "899511", "1006608", "1101926", "1101932"], "spl_set_id": ["edad7c67-a872-41ad-a8bd-169278693cc2"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-8109-37)", "package_ndc": "0527-8109-37", "marketing_start_date": "20181009"}], "brand_name": "Dexmethylphenidate Hydrochloride Extended-Release", "product_id": "0527-8109_05dde601-77db-4253-be20-c4737687633e", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0527-8109", "dea_schedule": "CII", "generic_name": "dexmethylphenidate hydrochloride", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexmethylphenidate Hydrochloride", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "DEXMETHYLPHENIDATE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA210279", "marketing_category": "ANDA", "marketing_start_date": "20181009", "listing_expiration_date": "20261231"}