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
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 20 mg/1

Manufacturer
XLCare Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72865-124
Product ID 72865-124_0a38c200-2e90-42b8-97e8-e5b64a7078e0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207416
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2020-02-26

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 72865124
Hyphenated Format 72865-124

Supplemental Identifiers

RxCUI
1091150 1091392 1091497
UPC
0372865124017 0372865123010 0372865122013
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 ANDA207416 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72865-124-01)
  • 500 TABLET in 1 BOTTLE (72865-124-05)
source: ndc

Packages (2)

72865-124-01 100 TABLET in 1 BOTTLE (72865-124-01) 72865-124-05 500 TABLET in 1 BOTTLE (72865-124-05)

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": "0a38c200-2e90-42b8-97e8-e5b64a7078e0", "openfda": {"upc": ["0372865124017", "0372865123010", "0372865122013"], "unii": ["4B3SC438HI"], "rxcui": ["1091150", "1091392", "1091497"], "spl_set_id": ["94dc74d4-b4ef-45bc-b502-54ec692e9bd5"], "manufacturer_name": ["XLCare Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72865-124-01)", "package_ndc": "72865-124-01", "marketing_start_date": "20200226"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72865-124-05)", "package_ndc": "72865-124-05", "marketing_start_date": "20200226"}], "brand_name": "METHYLPHENIDATE HYDROCHLORIDE", "product_id": "72865-124_0a38c200-2e90-42b8-97e8-e5b64a7078e0", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "72865-124", "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": "20 mg/1"}], "application_number": "ANDA207416", "marketing_category": "ANDA", "marketing_start_date": "20200226", "listing_expiration_date": "20261231"}