methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler bryant ranch prepack
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 10 mg/5mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-1176
Product ID 63629-1176_766addd2-4d8e-4ce0-b09b-746632c16ac6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210139
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-03-29

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 636291176
Hyphenated Format 63629-1176

Supplemental Identifiers

RxCUI
1091133
UNII
4B3SC438HI

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 ANDA210139 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 500 mL in 1 BOTTLE (63629-1176-1)
source: ndc

Packages (1)

63629-1176-1 500 mL in 1 BOTTLE (63629-1176-1)

Ingredients (1)

methylphenidate hydrochloride (10 mg/5mL)

Linked Drug Pages (1)

Methylphenidate Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "766addd2-4d8e-4ce0-b09b-746632c16ac6", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091133"], "spl_set_id": ["b49863bd-20ba-44d5-8dab-96fcbd276a5c"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BOTTLE (63629-1176-1)", "package_ndc": "63629-1176-1", "marketing_start_date": "20210629"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "63629-1176_766addd2-4d8e-4ce0-b09b-746632c16ac6", "dosage_form": "SOLUTION", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "63629-1176", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "ANDA210139", "marketing_category": "ANDA", "marketing_start_date": "20190329", "listing_expiration_date": "20261231"}