methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler lannett company, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 54 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 62175-313
Product ID 62175-313_9509caaf-43ee-4742-85f6-0fecbc9f8c0c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091695
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2013-09-23

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 62175313
Hyphenated Format 62175-313

Supplemental Identifiers

RxCUI
2001564 2001565 2001566 2001568
UPC
0362175312372 0362175311375
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 ANDA091695 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 54 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-313-37)
source: ndc

Packages (1)

62175-313-37 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-313-37)

Ingredients (1)

methylphenidate hydrochloride (54 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": "9509caaf-43ee-4742-85f6-0fecbc9f8c0c", "openfda": {"upc": ["0362175312372", "0362175311375"], "unii": ["4B3SC438HI"], "rxcui": ["2001564", "2001565", "2001566", "2001568"], "spl_set_id": ["3d1f5aff-5d39-496c-b5ed-7f3c70ec641c"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-313-37)", "package_ndc": "62175-313-37", "marketing_start_date": "20130923"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "62175-313_9509caaf-43ee-4742-85f6-0fecbc9f8c0c", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "62175-313", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "54 mg/1"}], "application_number": "ANDA091695", "marketing_category": "ANDA", "marketing_start_date": "20130923", "listing_expiration_date": "20271231"}