methylin

Generic: methylphenidate hydrochloride

Labeler: shionogi inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylin
Generic Name methylphenidate hydrochloride
Labeler shionogi inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 5 mg/5mL

Manufacturer
SHIONOGI INC.

Identifiers & Regulatory

Product NDC 59630-750
Product ID 59630-750_64c7c464-4ef5-401a-ab3c-c0443e5e31a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021419
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2002-12-19

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 59630750
Hyphenated Format 59630-750

Supplemental Identifiers

RxCUI
1091133 1091135 1091341 1091343
UPC
0359630755508 0359630750503
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 methylin (source: ndc)
Generic Name methylphenidate hydrochloride (source: ndc)
Application Number NDA021419 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 500 mL in 1 BOTTLE (59630-750-50)
source: ndc

Packages (1)

59630-750-50 500 mL in 1 BOTTLE (59630-750-50)

Ingredients (1)

methylphenidate hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Methylin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "64c7c464-4ef5-401a-ab3c-c0443e5e31a5", "openfda": {"upc": ["0359630755508", "0359630750503"], "unii": ["4B3SC438HI"], "rxcui": ["1091133", "1091135", "1091341", "1091343"], "spl_set_id": ["9e3c22d9-71d9-46a7-b315-8021c94c4bec"], "manufacturer_name": ["SHIONOGI INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BOTTLE (59630-750-50)", "package_ndc": "59630-750-50", "marketing_start_date": "20021219"}], "brand_name": "Methylin", "product_id": "59630-750_64c7c464-4ef5-401a-ab3c-c0443e5e31a5", "dosage_form": "SOLUTION", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "59630-750", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "SHIONOGI INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylin", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "NDA021419", "marketing_category": "NDA", "marketing_start_date": "20021219", "listing_expiration_date": "20261231"}