ritalin

Generic: methylphenidate hydrochloride

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

Drug Facts

Product Profile

Brand Name ritalin
Generic Name methylphenidate hydrochloride
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 5 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0439
Product ID 0078-0439_00db4d6e-410b-43a1-ab5e-7047f525e68d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA010187
DEA Schedule cii
Marketing Start 1955-12-31
Marketing End 2026-08-31

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 00780439
Hyphenated Format 0078-0439

Supplemental Identifiers

RxCUI
1091150 1091379 1091392 1091395 1091497 1091500
UPC
0300780441056 0300780439053
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 (source: ndc)
Generic Name methylphenidate hydrochloride (source: ndc)
Application Number NDA010187 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0078-0439-05)
source: ndc

Packages (1)

0078-0439-05 100 TABLET in 1 BOTTLE (0078-0439-05)

Ingredients (1)

methylphenidate hydrochloride (5 mg/1)

Linked Drug Pages (1)

Ritalin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "00db4d6e-410b-43a1-ab5e-7047f525e68d", "openfda": {"upc": ["0300780441056", "0300780439053"], "unii": ["4B3SC438HI"], "rxcui": ["1091150", "1091379", "1091392", "1091395", "1091497", "1091500"], "spl_set_id": ["c0bf0835-6a2f-4067-a158-8b86c4b0668a"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0078-0439-05)", "package_ndc": "0078-0439-05", "marketing_end_date": "20260731", "marketing_start_date": "19551231"}], "brand_name": "Ritalin", "product_id": "0078-0439_00db4d6e-410b-43a1-ab5e-7047f525e68d", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0078-0439", "dea_schedule": "CII", "generic_name": "methylphenidate hydrochloride", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ritalin", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "NDA010187", "marketing_category": "NDA", "marketing_end_date": "20260831", "marketing_start_date": "19551231"}