methylphenidate hydrochloride extended-release

Generic: methylphenidate hydrochloride

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

Drug Facts

Product Profile

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

methylphenidate hydrochloride 27 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-0127
Product ID 0406-0127_7a3a8731-e545-455e-83c3-888f4923e901
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202608
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2012-12-28

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 04060127
Hyphenated Format 0406-0127

Supplemental Identifiers

RxCUI
2001565 2001566 2001568
UPC
0304060154018 0304060136014 0304060127012
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 extended-release (source: ndc)
Generic Name methylphenidate hydrochloride (source: ndc)
Application Number ANDA202608 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 27 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-0127-01)
source: ndc

Packages (1)

0406-0127-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-0127-01)

Ingredients (1)

methylphenidate hydrochloride (27 mg/1)

Linked Drug Pages (1)

Methylphenidate Hydrochloride Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7a3a8731-e545-455e-83c3-888f4923e901", "openfda": {"upc": ["0304060154018", "0304060136014", "0304060127012"], "unii": ["4B3SC438HI"], "rxcui": ["2001565", "2001566", "2001568"], "spl_set_id": ["b1b0f2ff-d9df-42ab-b471-226ecf97e075"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-0127-01)", "package_ndc": "0406-0127-01", "marketing_start_date": "20121228"}], "brand_name": "Methylphenidate Hydrochloride Extended-Release", "product_id": "0406-0127_7a3a8731-e545-455e-83c3-888f4923e901", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0406-0127", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "27 mg/1"}], "application_number": "ANDA202608", "marketing_category": "ANDA", "marketing_start_date": "20121228", "listing_expiration_date": "20261231"}