ritalin la

Generic: methylphenidate hydrochloride

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ritalin la
Generic Name methylphenidate hydrochloride
Labeler novartis pharmaceuticals corporation
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 10 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0424
Product ID 0078-0424_8f4647d0-4965-4dee-8f60-1340ef9be3de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021284
DEA Schedule cii
Marketing Start 2002-06-05
Marketing End 2026-10-31

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 00780424
Hyphenated Format 0078-0424

Supplemental Identifiers

RxCUI
1091143 1091167 1091182 1091197 1806177 1806179 1806183 1806195
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 ritalin la (source: ndc)
Generic Name methylphenidate hydrochloride (source: ndc)
Application Number NDA021284 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0424-05)
source: ndc

Packages (1)

Ingredients (1)

methylphenidate hydrochloride (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "8f4647d0-4965-4dee-8f60-1340ef9be3de", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091143", "1091167", "1091182", "1091197", "1806177", "1806179", "1806183", "1806195"], "spl_set_id": ["effd952d-ac94-47bb-b107-589a4934dcca"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0424-05)", "package_ndc": "0078-0424-05", "marketing_end_date": "20260930", "marketing_start_date": "20020605"}], "brand_name": "Ritalin LA", "product_id": "0078-0424_8f4647d0-4965-4dee-8f60-1340ef9be3de", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0078-0424", "dea_schedule": "CII", "generic_name": "methylphenidate hydrochloride", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ritalin", "brand_name_suffix": "LA", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "NDA021284", "marketing_category": "NDA", "marketing_end_date": "20261031", "marketing_start_date": "20020605"}