methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler specgx llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 20 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-1473
Product ID 0406-1473_7bfd27d5-70ed-440b-949a-140aa3304d4a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075629
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2000-05-09

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 04061473
Hyphenated Format 0406-1473

Supplemental Identifiers

RxCUI
1091145 1091225
UPC
0304061473019 0304061445016
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 ANDA075629 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-1473-01)
source: ndc

Packages (1)

0406-1473-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-1473-01)

Ingredients (1)

methylphenidate hydrochloride (20 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": "7bfd27d5-70ed-440b-949a-140aa3304d4a", "openfda": {"upc": ["0304061473019", "0304061445016"], "unii": ["4B3SC438HI"], "rxcui": ["1091145", "1091225"], "spl_set_id": ["ed004cf0-eb23-43d2-96dc-20c4ad63824f"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-1473-01)", "package_ndc": "0406-1473-01", "marketing_start_date": "20000509"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "0406-1473_7bfd27d5-70ed-440b-949a-140aa3304d4a", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0406-1473", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA075629", "marketing_category": "ANDA", "marketing_start_date": "20000509", "listing_expiration_date": "20261231"}