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 TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 54 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 62037-727
Product ID 62037-727_7f865b23-e348-4b4a-84e1-5031dbd2cb4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076655
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-03-04

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 62037727
Hyphenated Format 62037-727

Supplemental Identifiers

RxCUI
1091155 1091170 1091185 1091210
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 ANDA076655 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 54 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62037-727-01)
source: ndc

Packages (1)

62037-727-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62037-727-01)

Ingredients (1)

methylphenidate hydrochloride (54 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": "7f865b23-e348-4b4a-84e1-5031dbd2cb4f", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091155", "1091170", "1091185", "1091210"], "spl_set_id": ["85ef422d-af27-4126-9841-6892af1871d6"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62037-727-01)", "package_ndc": "62037-727-01", "marketing_start_date": "20190304"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "62037-727_7f865b23-e348-4b4a-84e1-5031dbd2cb4f", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "62037-727", "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": "54 mg/1"}], "application_number": "ANDA076655", "marketing_category": "ANDA", "marketing_start_date": "20190304", "listing_expiration_date": "20261231"}