methylphenidate hydrochloride extended-release

Generic: methylphenidate hydrochloride

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride extended-release
Generic Name methylphenidate hydrochloride
Labeler specgx llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 50 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-1850
Product ID 0406-1850_8ba92af8-0db9-4347-95c3-bd06680fc85f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203583
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2015-09-29

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 04061850
Hyphenated Format 0406-1850

Supplemental Identifiers

RxCUI
1806181 1806187 1806189 1806191 1806193 1806197
UPC
0304061840019 0304061810012 0304061830010 0304061860017 0304061820011 0304061850018
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 methylphenidate hydrochloride extended-release (source: ndc)
Generic Name methylphenidate hydrochloride (source: ndc)
Application Number ANDA203583 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-1850-01)
source: ndc

Packages (1)

0406-1850-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-1850-01)

Ingredients (1)

methylphenidate hydrochloride (50 mg/1)

Linked Drug Pages (1)

Methylphenidate Hydrochloride Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8ba92af8-0db9-4347-95c3-bd06680fc85f", "openfda": {"upc": ["0304061840019", "0304061810012", "0304061830010", "0304061860017", "0304061820011", "0304061850018"], "unii": ["4B3SC438HI"], "rxcui": ["1806181", "1806187", "1806189", "1806191", "1806193", "1806197"], "spl_set_id": ["9e11e093-4ff3-4bed-8fe9-3ee460b47303"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-1850-01)", "package_ndc": "0406-1850-01", "marketing_start_date": "20150929"}], "brand_name": "Methylphenidate Hydrochloride Extended-Release", "product_id": "0406-1850_8ba92af8-0db9-4347-95c3-bd06680fc85f", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0406-1850", "dea_schedule": "CII", "generic_name": "methylphenidate hydrochloride", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA203583", "marketing_category": "ANDA", "marketing_start_date": "20150929", "listing_expiration_date": "20261231"}