methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: trigen laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC 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 63 mg/1

Manufacturer
Trigen Laboratories, LLC

Identifiers & Regulatory

Product NDC 13811-700
Product ID 13811-700_ba649db4-df0d-4587-8370-3f866e66e54b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA216117
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2022-06-23

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 13811700
Hyphenated Format 13811-700

Supplemental Identifiers

RxCUI
2605796 2605798
UPC
0313811700305 0313811711301
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 NDA216117 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 63 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-700-30)
source: ndc

Packages (1)

13811-700-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-700-30)

Ingredients (1)

methylphenidate hydrochloride (63 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": "ba649db4-df0d-4587-8370-3f866e66e54b", "openfda": {"upc": ["0313811700305", "0313811711301"], "unii": ["4B3SC438HI"], "rxcui": ["2605796", "2605798"], "spl_set_id": ["dd8d7b6e-c23d-4e16-bb53-959e9127ebc6"], "manufacturer_name": ["Trigen Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-700-30)", "package_ndc": "13811-700-30", "marketing_start_date": "20220623"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "13811-700_ba649db4-df0d-4587-8370-3f866e66e54b", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "13811-700", "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": "63 mg/1"}], "application_number": "NDA216117", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20220623", "listing_expiration_date": "20261231"}