methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: xlcare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler xlcare pharmaceuticals, inc.
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 10 mg/1

Manufacturer
XLCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72865-127
Product ID 72865-127_96784c11-8f1f-4073-9691-1a1627c79a61
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210354
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2018-03-01

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 72865127
Hyphenated Format 72865-127

Supplemental Identifiers

RxCUI
1091152 1091322 1091389
UPC
0372865125014 0372865127018 0372865126011
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 ANDA210354 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, CHEWABLE in 1 BOTTLE (72865-127-01)
source: ndc

Packages (1)

72865-127-01 100 TABLET, CHEWABLE in 1 BOTTLE (72865-127-01)

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": "96784c11-8f1f-4073-9691-1a1627c79a61", "openfda": {"upc": ["0372865125014", "0372865127018", "0372865126011"], "unii": ["4B3SC438HI"], "rxcui": ["1091152", "1091322", "1091389"], "spl_set_id": ["91833146-fa95-471a-8b8d-6d36a2db5c9a"], "manufacturer_name": ["XLCare Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (72865-127-01)", "package_ndc": "72865-127-01", "marketing_start_date": "20180301"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "72865-127_96784c11-8f1f-4073-9691-1a1627c79a61", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "72865-127", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "XLCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA210354", "marketing_category": "ANDA", "marketing_start_date": "20180301", "listing_expiration_date": "20261231"}