methylphenidate

Generic: methylphenidate hydrochloride

Labeler: kvk-tech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate
Generic Name methylphenidate hydrochloride
Labeler kvk-tech, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 10 mg/5mL

Manufacturer
KVK-Tech, Inc.

Identifiers & Regulatory

Product NDC 10702-164
Product ID 10702-164_445ee0dc-ce64-e21a-e063-6294a90ac320
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207485
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2017-01-23

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 10702164
Hyphenated Format 10702-164

Supplemental Identifiers

RxCUI
1091133 1091341
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 (source: ndc)
Generic Name methylphenidate hydrochloride (source: ndc)
Application Number ANDA207485 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 500 mL in 1 BOTTLE (10702-164-50)
source: ndc

Packages (1)

10702-164-50 500 mL in 1 BOTTLE (10702-164-50)

Ingredients (1)

methylphenidate hydrochloride (10 mg/5mL)

Linked Drug Pages (1)

Methylphenidate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "445ee0dc-ce64-e21a-e063-6294a90ac320", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091133", "1091341"], "spl_set_id": ["2cf1b26b-199d-4c7f-ab64-4805a9def2cc"], "manufacturer_name": ["KVK-Tech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BOTTLE (10702-164-50)", "package_ndc": "10702-164-50", "marketing_start_date": "20170123"}], "brand_name": "Methylphenidate", "product_id": "10702-164_445ee0dc-ce64-e21a-e063-6294a90ac320", "dosage_form": "SOLUTION", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "10702-164", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "KVK-Tech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "ANDA207485", "marketing_category": "ANDA", "marketing_start_date": "20170123", "listing_expiration_date": "20261231"}