methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler amneal pharmaceuticals of new york llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 20 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1737
Product ID 0115-1737_a1946373-6df9-4fd8-8c10-3d8d8b6ad9ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205105
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2016-09-20

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 01151737
Hyphenated Format 0115-1737

Supplemental Identifiers

RxCUI
1806181 1806187 1806189 1806191 1806193 1806197
UPC
0301151741010 0301157739011
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 ANDA205105 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1737-01)
source: ndc

Packages (1)

0115-1737-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1737-01)

Ingredients (1)

methylphenidate hydrochloride (20 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": "a1946373-6df9-4fd8-8c10-3d8d8b6ad9ef", "openfda": {"upc": ["0301151741010", "0301157739011"], "unii": ["4B3SC438HI"], "rxcui": ["1806181", "1806187", "1806189", "1806191", "1806193", "1806197"], "spl_set_id": ["10aa0dc0-bd0e-4927-a19a-8722d78ad67d"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1737-01)", "package_ndc": "0115-1737-01", "marketing_start_date": "20160920"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "0115-1737_a1946373-6df9-4fd8-8c10-3d8d8b6ad9ef", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0115-1737", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA205105", "marketing_category": "ANDA", "marketing_start_date": "20160920", "listing_expiration_date": "20261231"}