methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler actavis pharma, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 10 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-3854
Product ID 0591-3854_1895894a-ed70-4f82-b512-6bc184ee806c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208861
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-09-30

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 05913854
Hyphenated Format 0591-3854

Supplemental Identifiers

RxCUI
1648183 1806200 1806202 1806204 1806206 1806208 1806210
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 (source: ndc)
Generic Name methylphenidate hydrochloride (source: ndc)
Application Number ANDA208861 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0591-3854-19)
source: ndc

Packages (1)

0591-3854-19 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0591-3854-19)

Ingredients (1)

methylphenidate hydrochloride (10 mg/1)

Linked Drug Pages (1)

methylphenidate hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1895894a-ed70-4f82-b512-6bc184ee806c", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1648183", "1806200", "1806202", "1806204", "1806206", "1806208", "1806210"], "spl_set_id": ["ecbb4a30-21ac-42e1-b4e9-6c35344ffc45"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0591-3854-19)", "package_ndc": "0591-3854-19", "marketing_start_date": "20200930"}], "brand_name": "methylphenidate hydrochloride", "product_id": "0591-3854_1895894a-ed70-4f82-b512-6bc184ee806c", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0591-3854", "dea_schedule": "CII", "generic_name": "methylphenidate hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "methylphenidate hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA208861", "marketing_category": "ANDA", "marketing_start_date": "20200930", "listing_expiration_date": "20261231"}