methylphenidate hydrochloride (la) (0093-5346)

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride (la)

Generic Name methylphenidate hydrochloride

Labeler teva pharmaceuticals usa, inc.

Dosage Form CAPSULE, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

methylphenidate hydrochloride 20 mg/1

Manufacturer

Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-5346

Product ID 0093-5346_663ba889-95b5-45c2-af06-c90459d30d6d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA079031

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2012-07-16

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 00935346

Hyphenated Format 0093-5346

Supplemental Identifiers

RxCUI

1806177 1806179 1806183

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 (la) (source: ndc)

Generic Name methylphenidate hydrochloride (source: ndc)

Application Number ANDA079031 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1

source: ndc

Packaging

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5346-01)

source: ndc

Packages (1)

0093-5346-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5346-01)

Ingredients (1)

methylphenidate hydrochloride (20 mg/1)

Linked Drug Pages (1)

Methylphenidate Hydrochloride (LA) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "663ba889-95b5-45c2-af06-c90459d30d6d", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1806177", "1806179", "1806183"], "spl_set_id": ["034fb7cd-e183-475e-8beb-64fd88facc8f"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5346-01)", "package_ndc": "0093-5346-01", "marketing_start_date": "20120716"}], "brand_name": "Methylphenidate Hydrochloride (LA)", "product_id": "0093-5346_663ba889-95b5-45c2-af06-c90459d30d6d", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0093-5346", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "brand_name_suffix": "(LA)", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA079031", "marketing_category": "ANDA", "marketing_start_date": "20120716", "listing_expiration_date": "20261231"}