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
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 5 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-1142
Product ID 0406-1142_3c286d0f-d6c0-47f5-af8b-9a744477a11f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040300
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 1998-11-27

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 04061142
Hyphenated Format 0406-1142

Supplemental Identifiers

RxCUI
1091150 1091392 1091497
UPC
0304061144018 0304061146012 0304061142014
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 ANDA040300 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0406-1142-01)
  • 1000 TABLET in 1 BOTTLE (0406-1142-10)
source: ndc

Packages (2)

0406-1142-01 100 TABLET in 1 BOTTLE (0406-1142-01) 0406-1142-10 1000 TABLET in 1 BOTTLE (0406-1142-10)

Ingredients (1)

methylphenidate hydrochloride (5 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": "3c286d0f-d6c0-47f5-af8b-9a744477a11f", "openfda": {"upc": ["0304061144018", "0304061146012", "0304061142014"], "unii": ["4B3SC438HI"], "rxcui": ["1091150", "1091392", "1091497"], "spl_set_id": ["981a2ad8-33f7-4678-9162-9df9685bd4a6"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0406-1142-01)", "package_ndc": "0406-1142-01", "marketing_start_date": "19981127"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (0406-1142-10)", "package_ndc": "0406-1142-10", "marketing_start_date": "19981127"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "0406-1142_3c286d0f-d6c0-47f5-af8b-9a744477a11f", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0406-1142", "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": "5 mg/1"}], "application_number": "ANDA040300", "marketing_category": "ANDA", "marketing_start_date": "19981127", "listing_expiration_date": "20261231"}