methylphenidate hydrochloride extended release (10702-075)

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride extended release

Generic Name methylphenidate hydrochloride extended release

Labeler kvk-tech, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

methylphenidate hydrochloride 10 mg/1

Manufacturer

KVK-Tech, Inc.

Identifiers & Regulatory

Product NDC 10702-075

Product ID 10702-075_40950048-0e42-4661-e063-6394a90a2bb1

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207488

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2015-06-09

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 10702075

Hyphenated Format 10702-075

Supplemental Identifiers

RxCUI

1091145 1091225

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 extended release (source: ndc)

Application Number ANDA207488 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (10702-075-01)
60 TABLET in 1 BOTTLE (10702-075-06)

source: ndc

Packages (2)

10702-075-01 100 TABLET in 1 BOTTLE (10702-075-01) 10702-075-06 60 TABLET in 1 BOTTLE (10702-075-06)

Ingredients (1)

methylphenidate hydrochloride (10 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": "40950048-0e42-4661-e063-6394a90a2bb1", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091145", "1091225"], "spl_set_id": ["be8580bc-0eb2-4eb6-a4cc-4ebbeb33424d"], "manufacturer_name": ["KVK-Tech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (10702-075-01)", "package_ndc": "10702-075-01", "marketing_start_date": "20150609"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (10702-075-06)", "package_ndc": "10702-075-06", "marketing_start_date": "20150609"}], "brand_name": "METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE", "product_id": "10702-075_40950048-0e42-4661-e063-6394a90a2bb1", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "10702-075", "dea_schedule": "CII", "generic_name": "methylphenidate hydrochloride extended release", "labeler_name": "KVK-Tech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA207488", "marketing_category": "ANDA", "marketing_start_date": "20150609", "listing_expiration_date": "20261231"}