methylphenidate hydrochloride (la) (51862-612)

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride (la)

Generic Name methylphenidate hydrochloride

Labeler mayne pharma

Dosage Form CAPSULE, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

methylphenidate hydrochloride 40 mg/1

Manufacturer

Mayne Pharma

Identifiers & Regulatory

Product NDC 51862-612

Product ID 51862-612_42f2646f-1d99-46f5-e063-6394a90a8e5e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078458

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2018-12-06

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 51862612

Hyphenated Format 51862-612

Supplemental Identifiers

RxCUI

1806177 1806179 1806183 1806185 1806195

UPC

0351862614301

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 ANDA078458 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

40 mg/1

source: ndc

Packaging

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51862-612-01)

source: ndc

Packages (1)

51862-612-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51862-612-01)

Ingredients (1)

methylphenidate hydrochloride (40 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": "42f2646f-1d99-46f5-e063-6394a90a8e5e", "openfda": {"upc": ["0351862614301"], "unii": ["4B3SC438HI"], "rxcui": ["1806177", "1806179", "1806183", "1806185", "1806195"], "spl_set_id": ["e5db854a-1c77-4faf-9e60-daf9c9b6cfa0"], "manufacturer_name": ["Mayne Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51862-612-01)", "package_ndc": "51862-612-01", "marketing_start_date": "20190610"}], "brand_name": "Methylphenidate Hydrochloride (LA)", "product_id": "51862-612_42f2646f-1d99-46f5-e063-6394a90a8e5e", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "51862-612", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "Mayne Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride (LA)", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA078458", "marketing_category": "ANDA", "marketing_start_date": "20181206", "listing_expiration_date": "20261231"}