methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: solco healthcare us,llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler solco healthcare us,llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 10 mg/1

Manufacturer
Solco Healthcare US,LLC

Identifiers & Regulatory

Product NDC 43547-487
Product ID 43547-487_393f91b9-9211-479f-b422-64cc81460623
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212697
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-07-01

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 43547487
Hyphenated Format 43547-487

Supplemental Identifiers

RxCUI
1091150 1091392 1091497
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 ANDA212697 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (43547-487-10)
source: ndc

Packages (1)

43547-487-10 100 TABLET in 1 BOTTLE (43547-487-10)

Ingredients (1)

methylphenidate hydrochloride (10 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": "393f91b9-9211-479f-b422-64cc81460623", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091150", "1091392", "1091497"], "spl_set_id": ["238ff743-4f25-43a3-87ac-6559d12a9d49"], "manufacturer_name": ["Solco Healthcare US,LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (43547-487-10)", "package_ndc": "43547-487-10", "marketing_start_date": "20200701"}], "brand_name": "Methylphenidate hydrochloride", "product_id": "43547-487_393f91b9-9211-479f-b422-64cc81460623", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "43547-487", "dea_schedule": "CII", "generic_name": "Methylphenidate hydrochloride", "labeler_name": "Solco Healthcare US,LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA212697", "marketing_category": "ANDA", "marketing_start_date": "20200701", "listing_expiration_date": "20261231"}