methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: trigen laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler trigen laboratories, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 27 mg/1

Manufacturer
Trigen Laboratories, LLC

Identifiers & Regulatory

Product NDC 13811-707
Product ID 13811-707_da71a915-393d-4af3-9e41-3fd4a25dc652
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205327
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2017-08-14

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 13811707
Hyphenated Format 13811-707

Supplemental Identifiers

RxCUI
1091155 1091170 1091185 1091210 1995461
UPC
0313811706109 0313811708103
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 ANDA205327 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 27 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-707-10)
source: ndc

Packages (1)

13811-707-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-707-10)

Ingredients (1)

methylphenidate hydrochloride (27 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": "da71a915-393d-4af3-9e41-3fd4a25dc652", "openfda": {"upc": ["0313811706109", "0313811708103"], "unii": ["4B3SC438HI"], "rxcui": ["1091155", "1091170", "1091185", "1091210", "1995461"], "spl_set_id": ["c45dc1de-adfa-4b3c-a7dc-cffbc8eac74f"], "manufacturer_name": ["Trigen Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-707-10)", "package_ndc": "13811-707-10", "marketing_start_date": "20170814"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "13811-707_da71a915-393d-4af3-9e41-3fd4a25dc652", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "13811-707", "dea_schedule": "CII", "generic_name": "Methylphenidate hydrochloride", "labeler_name": "Trigen Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "27 mg/1"}], "application_number": "ANDA205327", "marketing_category": "ANDA", "marketing_start_date": "20170814", "listing_expiration_date": "20271231"}